Implementation Engineer Salary in Norwood, MA

The Role:Moderna is seeking an Sr Engineer I for a position in the Systems Integration (SI) team, at the Moderna manufacturing site in Norwood, MA to drive the advancement of our next generation integrated hardware and digital systems. Reporting to the Principal Engineer, Applied Technologies, the individual in this role will focus on leading the design, development, and implementation of innovative integration solutions for various hardware and software systems, applications, and modules that optimize Moderna's operations and contribute to the production of messenger RNA based vaccines and therapeutics. The individual in this role with play a key role in leading the design, build, testing, deployment, and continuous improvement lifecycles of key integrated digital and hardware systems deployed at Moderna. This role will have an impact across our organization by driving cross functional collaboration between software developers, scientists, lab automation engineers, and other IT staff to ensure seamless integration and adoption of integrated technologies across the Research, Development, High-Throughput, Pre-Clinical, and GMP laboratories at Moderna.Here's What You'll Do:Lead the design, development, and implementation of novel integration solutions to integrate Moderna's diverse software and hardware systems, processes, and methodologies.Drive collaboration with software architects, developers, lab automation engineers, scientists across the organization to establish and document functional requirements and technical design descriptions for integrated systems.Manage the development of design documentation and process maps for integrated systems.Lead the execution of system integration testing and interface testing.Manage release process and configuration management for integration software solutions.Monitor system performance post-integration and make necessary adjustments to ensure optimal performance.Oversee change management of integrated systems in accordance with regulations and standards.Lead efforts for training end users ensuring seamless adoption of novel integration solutions.Lead coordination efforts with internal and external groups to identify appropriate solutions to improve efficiencies in laboratory workflows.Mentor and provide guidance to junior system integration engineers.Manage multiple projects, and interactions with supporting functions simultaneously.Lead troubleshooting of integrated systems as needed.Keep up to date with the latest industry trends and technologies.Here is What You'll Bring to the Table:Minimum Qualifications:Bachelor's degree in systems engineering, Computer science, Information Systems, Bioengineering, Chemical Engineering, or a related field with no less than 8 years' experience in an industry setting.Proven experience as a Systems Integration Engineer or similar role preferably in healthcare industry with several years in a senior or lead position.Excellent project management skills with the ability to manage multiple projects within established timelines.Extensive experience with various programming languages, such as Java, Python, C#, or C++.Extensive Knowledge of databases, system architecture, and networking.Knowledge of REST and SOAP APIs, API gateways, and other API technologies.Knowledge of distributed messaging systems and protocols such as Apache Kafka, MQTTT.Knowledge of laboratory information management systems (LIMS), electronic lab notebooks (ELN), and other laboratory software.Familiarity with software development methodologies and the software development lifecycle (SDLC).Familiarity with Atlassian tools for version control (Bitbucket) and issue management (Jira).Experience with using requirement, design and test management tools such as JAMA, code beamer, qTest etc.Understanding of regulations and standards for medical device software (such as FDA regulations, ISO 13485, IEC 62304).Exceptional written and oral communication.Preferred Qualifications:M.S. in systems engineering, Computer science, Information Systems, Bioengineering, Chemical Engineering, or a related field with no less than 5 years' experience in a relevant industry or PhD with academic experience in a related field.Familiarity with laboratory operations and programming automated laboratory systems such as Hamilton, Tecan, Beckman Coulter, or Agilent is a plus.Experience with automation scheduling/control software (Green Button Go, Overlord, Momentum, Cellario etc.) is a plus.Experience with programming and operating robotic systems is a plus.Experience with web frameworks such as Django, Flask, Express, Ruby etc. is a plus.Experience with design and implementation of firmware for embedded systems is a plus.Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:Highly competitive and inclusive medical, dental and vision coverage optionsFlexible Spending Accounts for medical expenses and dependent care expensesLifestyle Spending Account funds to help you engage in personal enrichment and self-care activitiesFamily care benefits, including subsidized back-up care options and on-demand tutoringFree premium access to fitness, nutrition, and mindfulness classes Exclusive preferred pricing on Peloton fitness equipmentAdoption and family-planning benefitsDedicated care coordination support for our LGBTQ+ communityGenerous paid time off, including:• Vacation, sick time and holidays• Volunteer time to participate within your community• Discretionary year-end shutdown• Paid sabbatical after 5 years; every 3 years thereafterGenerous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents 401k match and Financial Planning toolsModerna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit optionsComplimentary concierge service including home services research, travel booking, and entertainment requestsFree parking or subsidized commuter passesLocation-specific perks and extras! About ModernaSince our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.Moderna is a smoke-free, alcohol-free and drug-free work environment.Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at [email protected]. (EEO/AAP Employer) -

The Role:The Sr. Manager, MS&T, will be part of Moderna's Manufacturing Science and Technology team responsible for process implementation, technical support, and person-in-plant coverage to ensure robust production of our DNA plasmid, chemistry, and small-scale drug substance processes. The individual will lead a team and work collaboratively with cross functional stakeholders such as Technical Development, Manufacturing, Regulatory, and Quality, to ensure all technical aspects of production are successfully executed. Here's What You'll Do:Provide expertise in unit operations and cGMP manufacturing, responsible for technical support, change control, safety observations, manufacturing investigations, and person-in-plant coverage for the manufacturing process.Support process training for GMP operations and development of process understanding and expertise.Lead/participate in cross functional technical process support and investigation teams. Partner with Technical Development, Manufacturing, and Quality to enable and sustain cGMP processes. Be the technical lead supporting cGMP manufacturing activities.Lead a team of subject matter experts in plasmid, chemistry, and small-scale drug substance processes.Be the subject matter expert for plasmid, chemistry, and small-scale drug substance processes. This includes troubleshooting process and equipment issues.Independently provide complex technical support of cGMP manufacturing including authoring of complex technology transfer documents, change controls, manufacturing impact assessments, and study protocols.Lead complex analysis and review of data. Proactively identify improvement projects and performance risks.Here's What You'll Bring to the Table:Biochemical engineer, Chemical engineer, Biochemistry, Biology, or STEM background. BS with 10+ years of experience or MS with 8+ years' experience in a pharmaceutical or biotechnology company.Demonstrated knowledge of cGMPs and experience providing technical support in a cGMP manufacturing environment.Demonstrated expertise bioprocessing including purification of protein and/or nucleic acids. Expertise in at least one of the following areas: chromatography, membrane separations, enzymatic reactions, and formulation.Technical agility. The capability to manage diverse technical areas.Ability to collaborate effectively in a dynamic, cross-functional matrix environment.Preferred: Expertise in molecular biologyPreferred: Experience in biologics process development and scale up / scale down.Preferred: Experience with single use bioprocessing technologies.Preferred: Proven track record leading and managing cross functional teams.Preferred: Knowledge of digital cGMP tools. For example: SAP, OSI PI(), MES (eBR), Unicorn, eQMSModerna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:Highly competitive and inclusive medical, dental and vision coverage optionsFlexible Spending Accounts for medical expenses and dependent care expensesLifestyle Spending Account funds to help you engage in personal enrichment and self-care activitiesFamily care benefits, including subsidized back-up care options and on-demand tutoringFree premium access to fitness, nutrition, and mindfulness classes Exclusive preferred pricing on Peloton fitness equipmentAdoption and family-planning benefitsDedicated care coordination support for our LGBTQ+ communityGenerous paid time off, including:• Vacation, sick time and holidays• Volunteer time to participate within your community• Discretionary year-end shutdown• Paid sabbatical after 5 years; every 3 years thereafterGenerous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents 401k match and Financial Planning toolsModerna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit optionsComplimentary concierge service including home services research, travel booking, and entertainment requestsFree parking or subsidized commuter passesLocation-specific perks and extras! About ModernaSince our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.Moderna is a smoke-free, alcohol-free and drug-free work environment.Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at [email protected]. (EEO/AAP Employer) -

The Role:Moderna is seeking an Engineer I to join the Process Development team to support development, scale up, transfer and commercialization of drug substances based on mRNA and lipid nanoparticle delivery technologies.Moderna is developing first-in-class mRNA-based vaccines and therapeutics. The mRNA is packaged into lipid nanoparticles for storage and delivery. The candidate will be focused on unit operations that are standard across the industry such as enzymatic reactions, normal and tangential flow filtration and chromatographic purification. The candidate will support commercial manufacturing processes and execute experiments to support deviation investigations and definition of appropriate process controls to increase process robustness.Applicants should enjoy working in a fast-paced, dynamic, and innovative environment. The successful candidate will possess strong skills in designing and executing high quality bioprocess experiments using quality by design (QbD) and Design of Experiment (DoE) methods, and will collaborate through cross-functional matrix teams. The person in this role will have the opportunity to develop on-line analytics, process modelling and process investigation support. Results will be presented to broader groups allowing great exposure to CMC Strategy, Regulatory, MS&T, and Quality. Prior experience of process development and process investigation accomplishments using scaled down models, QbD-principles and process characterization/modeling techniques are strong pluses.In this role, multi-day domestic and/or international travel (up to 20%) should be expected to support process investigations, support technology transfer and provide Person-in-Plant (PiP) support for commercial batches. The position will be based out of Moderna's Norwood facility.Here's What You'll Do:Design, execute, and analyze experiments for existing and novel process modes using DoE and statistical modelingDefine the process, the critical parameters, and the design spaceCreate high throughput and automated experimental setupsLead experiments to confirm robust process performance across the control spaceCharacterize mRNA properties through collaboration with the analytical teamPrepare process descriptions, technical reports, and communicate findings internally and externally as appropriateCollect and share relevant academic literature, leverage external consultants/SMEs, and establish new collaborations with internal groups.Here's What You'll Bring to the Table:BS/MS degree in Bio/Chemical Engineering, Bio/Chemistry, Pharmaceutical Science, or related fieldHands on experience with chromatography, ultrafiltration, normal flow filtration, and development of innovative unit operationsWorking knowledge of statistical design of experiments (DoE) and analysis of multivariate dataExperience with analytics and biophysical characterization of nanoparticles is a plusKnowledge of cGMP, ICH, regulatory guidelines and QbD principles as they apply to risk management and product commercializationDemonstrated background of providing technical support to commercial manufacturing processes, including but not limited to, support of process investigations, implementation of pro-active process modifications and support of post-approval changes is a plusKnowledge of nucleic acid chemistry, lipid chemistry, and biology is a plusAbility to thrive in a diverse and fast paced environmentExcellent written and verbal communication skillsModerna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:Highly competitive and inclusive medical, dental and vision coverage optionsFlexible Spending Accounts for medical expenses and dependent care expensesLifestyle Spending Account funds to help you engage in personal enrichment and self-care activitiesFamily care benefits, including subsidized back-up care options and on-demand tutoringFree premium access to fitness, nutrition, and mindfulness classes Exclusive preferred pricing on Peloton fitness equipmentAdoption and family-planning benefitsDedicated care coordination support for our LGBTQ+ communityGenerous paid time off, including:• Vacation, sick time and holidays• Volunteer time to participate within your community• Discretionary year-end shutdown• Paid sabbatical after 5 years; every 3 years thereafterGenerous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents 401k match and Financial Planning toolsModerna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit optionsComplimentary concierge service including home services research, travel booking, and entertainment requestsFree parking or subsidized commuter passesLocation-specific perks and extras! About ModernaSince our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.Moderna is a smoke-free, alcohol-free and drug-free work environment.Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at [email protected]. (EEO/AAP Employer) -

The Role:This role will be responsible for ensuring continuous improvement and sustained compliance of GMP manufacturing process equipment located at the Moderna manufacturing facilities. This position will provide engineering support for utilities and HVAC to the campus, support in the execution of day-to-day operation, projects, and troubleshooting. Lead investigations relating to non-conformance events in partnership with Quality, IT, and Manufacturing. Applicants should enjoy working in a fast-paced, dynamic, and innovative environment.Proven problem-solving skills with a proactive, field-based approach for project and deviation management required. Ability to develop and drive continuous improvement initiatives is essential. Strong technical writing, problem solving skills, data analysis, and development and implementation of effective corrective and preventative action based on investigations is required.Here's What You'll Do:Provide direct engineering support and Subject Matter Expertise for plant and clean utility system (purified water system, WFI, autoclaves, process gasses, HVAC, etc.) This includes serving as the system owner for plant and clean utility systems.Using risk-based approaches and a deep understanding of equipment, design and optimize unit operations for early-stage manufacturing processes.Lead and manage large sized, complex projects. Skills required to meet expectations of the role include high quality technical writing within the required quality systems and meeting the project timelines to ensure the production schedule is not impacted. Manage project teams through all phases of engineering projects related to process equipment including conceptual design, detailed design, equipment procurement, construction, installation, start up, commissioning, validation, and qualification of facilities and/or equipment.Troubleshoot equipment to determine root cause of failure modes, independently drive failure resolution, owning Corrective/Preventative Actions and associated change controls.Candidate must be able to drive results on multiple complex assignments simultaneously with minimal required direction from his/her supervisor, in addition to reviewing and guiding the work and performance of contractors.Collaborate with Quality functions to streamline processes and remove obstacles to allow for agile and compliant project execution.Own quality records such as Change Controls, Deviations, and CAPAs, related to plant utility systems, as required. Provide input into preventative maintenance plans, assessing change controls, and continuous improvement initiatives.Here's What You'll Bring to the Table:Bachelor's degree EngineeringMinimum of 5 years relevant experience preferably as a Plant Engineer5 years of experience in a GxP biopharmaceutical operations environment preferred.Experience with plant and clean utility systems. Excellent interpersonal and communication skills (verbal and written) are required. Expected to be able to present own work to peers and cross-functional managers and influence leadership decisions. Technical writing skills required.Must be able use his/her technical background to investigate issues using a structured problem-solving approach to determine true root cause and develop effective corrective and preventative actions. Must be able to be able to find true root cause and path forward for complex problems. A comprehensive understanding of regulatory requirements and their applications in a cGMP environmentFamiliarity with Excel, Word, and PowerPoint are required, and basic statistical analysis techniques are preferred.Ability to interact well with other groups and must be able to take ownership of and follow through on assignments. Must be able to drive results on multiple complex assignments simultaneously with minimal required direction from his/her supervisor.Ability to represent Moderna's interests, objectives, and policies in a professional and responsible manner.Experience working with electronic systems and thorough understanding of 21 CFR part 11, 210, and 211 requirements.Experience interacting with representatives of regulatory agencies.Experience with facility, utility, systems, and equipment commissioning and qualification.Excellent written and oral English language skillsProject management experienceModerna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:Highly competitive and inclusive medical, dental and vision coverage optionsFlexible Spending Accounts for medical expenses and dependent care expensesLifestyle Spending Account funds to help you engage in personal enrichment and self-care activitiesFamily care benefits, including subsidized back-up care options and on-demand tutoringFree premium access to fitness, nutrition, and mindfulness classes Exclusive preferred pricing on Peloton fitness equipmentAdoption and family-planning benefitsDedicated care coordination support for our LGBTQ+ communityGenerous paid time off, including:• Vacation, sick time and holidays• Volunteer time to participate within your community• Discretionary year-end shutdown• Paid sabbatical after 5 years; every 3 years thereafterGenerous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents 401k match and Financial Planning toolsModerna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit optionsComplimentary concierge service including home services research, travel booking, and entertainment requestsFree parking or subsidized commuter passesLocation-specific perks and extras! About ModernaSince our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.Moderna is a smoke-free, alcohol-free and drug-free work environment.Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at [email protected]. (EEO/AAP Employer) #LI-NB1-

The Role:Moderna is seeking an Engineer III for a position in the Systems Integration (SI) team, at the Moderna manufacturing site in Norwood, MA to drive the advancement of our next generation integrated hardware and digital systems. Reporting to the Principal Engineer, Applied Technologies, the individual in this role will focus on the design, development, and implementation of innovative integration solutions for various hardware and software systems, applications, and modules that optimize Moderna's operations and contribute to the production of messenger RNA based vaccines and therapeutics.The individual in this role with play a key role in the design, build, testing, deployment, and continuous improvement lifecycles of key integrated digital and hardware systems deployed at Moderna. This role will have an impact across our organization by driving cross functional collaboration between software developers, scientists, lab automation engineers, and other IT staff to ensure seamless integration and adoption of integrated technologies across the Research, Development, High-Throughput, Pre-Clinical, and GMP laboratories at Moderna.Here's What You'll Do:Design and implement solutions to integrate Moderna's diverse software and hardware systems, processes, and methodologies.Collaborate with software architects, developers, lab automation engineers, scientists across the organization to establish and document functional requirements and technical design descriptions for integrated systems.Establish release process and configuration management for integrated software solutions.Develop and maintain design documentation and process maps for integrated systems.Conduct system integration and interface testing.Monitor system performance post-integration and make necessary adjustments to ensure optimal performance.Support troubleshooting of integrated systems as needed.Prepare documentation and presentations for training end users on integration solutions.Coordinate with internal and external groups to identify appropriate software solutions to improve efficiencies in laboratory workflows.Keep up to date with the latest industry trends and technologies.Here is What You'll Bring to the Table:Minimum Qualifications:Bachelor's degree in systems engineering, Computer science, Information Systems, Bioengineering, Chemical Engineering, or a related field with no less than 5 years' experience in an industry setting.Proven experience as a Systems Integration Engineer or similar role preferably in healthcare industry.Experience with developing system analysis, risk analysis and/or vulnerability assessments.Experience with various programming languages, such as Java, Python, C#, or C++.Knowledge of databases, system architecture, and networking.Knowledge of REST and SOAP APIs, API gateways, and other API technologies.Knowledge of distributed messaging systems and protocols such as Apache Kafka, MQTTT etc.Knowledge of laboratory information management systems (LIMS), electronic lab notebooks (ELN), and other laboratory software.Familiarity with software development methodologies and the software development lifecycle (SDLC).Experience with using requirement, design and test management tools such as JAMA, code beamer, qTest etc.Familiarity with Atlassian tools for version control (Bitbucket) and issue management (Jira).Excellent written and oral communication.Preferred Qualifications:Master's degree in systems engineering, Computer science, Information Systems, Bioengineering, Chemical Engineering, or a related field with no less than 2 years' experience in an industry setting.Understanding of regulations and standards for medical device software (such as FDA regulations, ISO 13485, IEC 62304) is plus.Familiarity with laboratory operations and programming automated laboratory systems such as Hamilton, Tecan, Beckman Coulter, or Agilent is a plus.Experience with automation scheduling/control software (Green Button Go, Overlord, Momentum, Cellario etc.) is a plus.Experience with programming and operating robotic systems is a plus.Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:Highly competitive and inclusive medical, dental and vision coverage optionsFlexible Spending Accounts for medical expenses and dependent care expensesLifestyle Spending Account funds to help you engage in personal enrichment and self-care activitiesFamily care benefits, including subsidized back-up care options and on-demand tutoringFree premium access to fitness, nutrition, and mindfulness classes Exclusive preferred pricing on Peloton fitness equipmentAdoption and family-planning benefitsDedicated care coordination support for our LGBTQ+ communityGenerous paid time off, including:• Vacation, sick time and holidays• Volunteer time to participate within your community• Discretionary year-end shutdown• Paid sabbatical after 5 years; every 3 years thereafterGenerous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents 401k match and Financial Planning toolsModerna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit optionsComplimentary concierge service including home services research, travel booking, and entertainment requestsFree parking or subsidized commuter passesLocation-specific perks and extras! About ModernaSince our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.Moderna is a smoke-free, alcohol-free and drug-free work environment.Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at [email protected]. (EEO/AAP Employer) -

The Role:Moderna is seeking a highly skilled and motivated Senior Engineer to join our Drug Product Development (DPD) team in Norwood, MA, to support development of Moderna's device combination products. The primary role for this position will be to support drug product development activities including: device development, combination product development and packaging development. Specifically, the applicant will be responsible for Human Factors Engineering activities related to Moderna's combination products. Applicants should have relevant device engineering related experience in the pharmaceutical space. The applicant should have exceptional ability to plan, execute and report, to communicate and collaborate, and requires strong attention to detail while working in a fast-paced, interdisciplinary environment.Here's What You'll Do:Lead human factors engineering activities on drug delivery device technology development and/or drug-device combination product programs. Be involved in problem solving and utilization of different strategies to support resolution of design, risk and regulatory challenges. Help establish and develop of human factors engineering strategies for drug delivery combination product. Ensure user needs are considered early and continuously throughout the design process. Manage and support the execution of early patient handling studies, identify and maintenance of user needs, conduct user related risk assessments and perform ethnographic analysis. Plan and support the execution of design validation studies. Author and/or provide oversight to human factors documents for device and combination product design history files. Interacting with external human factors vendors and senior leaders with regards to human factors strategy and implementation. Assist in platform device and packaging design and development identifying ways improve platform efficiency.Support the team by managing action plans and project plans to deliver short-, mid- and long-term development goals.Effectively communicate your work to the wider development team and stakeholders.Manage external vendors or partners as required to advance project milestones.Provide mentorship to junior scientists/engineers to develop appropriate internal capability.Maintain accountability for project success and results delivery.Support authoring and review of regulatory submissions and written responses.Here's What You'll Bring to the Table:BS (8+ years), MS (5+ years) or PhD in Human Factors/Systems/Biomedical Engineering, Pharmaceutical Sciences, Biochemistry or related scientific disciplines with industry experience in small and/or large molecule combination drug product development.Exceptional laboratory skills and hands-on experience with aseptic liquid filling and handling of vials, pre-filled syringes, and/or cartridges. Familiar with current varieties and suppliers of parenteral container closure systems.Experience in clinical or commercial Drug Product (or related) GMP technology transfer and validation would be a plus.Ability to perform data analysis using advanced statistical, including design of experiments (DoE) approaches leveraging statistical analysis softwareExperience working in matrix project teams with members from peer groups, CMC teams, R&D, CMOs and CROs.Knowledge of GMP and GLP complianceModerna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:Highly competitive and inclusive medical, dental and vision coverage optionsFlexible Spending Accounts for medical expenses and dependent care expensesLifestyle Spending Account funds to help you engage in personal enrichment and self-care activitiesFamily care benefits, including subsidized back-up care options and on-demand tutoringFree premium access to fitness, nutrition, and mindfulness classes Exclusive preferred pricing on Peloton fitness equipmentAdoption and family-planning benefitsDedicated care coordination support for our LGBTQ+ communityGenerous paid time off, including:• Vacation, sick time and holidays• Volunteer time to participate within your community• Discretionary year-end shutdown• Paid sabbatical after 5 years; every 3 years thereafterGenerous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents 401k match and Financial Planning toolsModerna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit optionsComplimentary concierge service including home services research, travel booking, and entertainment requestsFree parking or subsidized commuter passesLocation-specific perks and extras! About ModernaSince our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.Moderna is a smoke-free, alcohol-free and drug-free work environment.Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at [email protected]. (EEO/AAP Employer) -

The Role: Reporting to the SVP Facilities and Engineering, based at our Norwood, MA site,the Senior Director of Global Engineering is a technical leadership position at the organization, one which has primary responsibility for leading the conceptual and detailed engineering of new manufacturing and R&D facilities worldwide. The candidate will lead a group of subject matters experts across multiple disciplines including Plasmid, mRNA Drug Substance, mRNA Drug Product Manufacturing, Plant and Clean Utilities including HVAC. The position requires broad engineering knowledge of the Drug Substance and Drug Product Manufacturing Technologies. It also requires strong project management skills with the ability to keep multiple projects on their timelines and on budgets in a fast based and demanding environment. Candidate must have a strong process approach and an eye toward continuous improvement with as are strong organizational skills and written and verbal communication skills.Candidate should have knowledge of regulatory and performance requirements for pharmaceutical manufacturing facilities. Candidate will establish and lead a local team of project delivery and manufacturing support resources (Process Engineering for Drug Substance and Drug product Manufacturing, Plant and GMP Utilities) at remote locations for project execution. Candidate would be responsible for overall project delivery up to Operational Readiness milestone. Travel to support global manufacturing expansion could be up to 25% at critical project phases. Here's What You Will Do:Partners with the Capital Project Delivery and Project Control Team in the delivery of manufacturing, Office, and R&D facilities worldwide.Lead combines technical team of mRNA Drug Substance process engineer, facilities and utilities engineers, process improvement, Sterile Filling, Automatic Inspection and Packaging, on capital projects delivery in compliance with regulatory standards. Ensure good engineering practices are followed through for the performance of control and coordination activities on all process phases (planning, development, approval, and implementation); integration and synergies between Global and local requirements; ensure maintenance and operations best practices and guidelines sharing across Moderna's mfg. networkStrategic and tactical leadership of design, construction, commissioning, qualification (if applicable) and operational readiness workstreams for capital project portfolio.Partner with MS&T (Manufacturing Sciences & Technology) (Manufacturing Sciences & Technology) and Technical Development organizations in the development of novel manufacturing technologies around Moderna's mRNA platform.Provide input to short- and long-term capital planningOwn and drive energy reduction program for the site through conservation, new equipment, and technologies to reduce overall costs and drive sustainabilityWorking closely with procurement, direct the bid evaluation and contract award processes and coordinate the negotiation of contracts with engineering firms, process equipment vendors, skid, and oversight of equipment acquisition activitiesProvide leadership in the management of external design team professionals from project inception through completion and ensure they produce thorough and accurate drawings which comply with all established standardsEnsure review of all construction drawing documents and specifications, coordinating necessary reviews with business unit representatives and regulatory authoritiesCoordinate with internal stakeholders to insure efficient and timely turnover of space for effective operations, including a maintenance and calibration packageOversee relationship with the local municipality authorities for project permitting and other business related to site improvementsRecruit and hire top engineering talentGrow and mentor process engineering teams at manufacturing sitesWork with the Engineering leadership to scale the engineering organization as required by Moderna's growth.Here's What You Will Bring to the Table:At least 20 years of relevant experience working with engineering project delivery, construction capital projects or 15+ years with master's degree in engineering, preferably in a pharmaceutical/FDA-regulated work environment.A professional and advanced degree in Engineering. Chemical Engineering background is preferred.10 or more years' experience leading others on project teams, interfacing and influencing at executive levels.Substantial operational engineering experienceBroad knowledge of engineering aspects associated with pharmaceutical drug substance and drug product manufacturingKnowledge of Quality Assurance (QA) and Environmental, Health & Safety (EHS) standardsExperience working to regulatory standards: FDA (Food and Drug Administration), Good Engineering Practice (GEP), Good Manufacturing Procedures (GMP) and Good Documentation Procedures (GDP)Experienced working on all aspects of capital projects, including budgeting, design, construction, validation, start-up, and ongoing operations will be a plus.Relevant experience in Central Utilities including, but not limited to: WFI (Water for Injection), and Purified Water, Compressed Air, N2, Chilled Water, Steam, Heating Hot Water, Electricity and SewageExcellent negotiation, organizational, interpersonal, and problem-solving skills Working Knowledge of Large and Small Molecule manufacturing including fermentation and chemical synthesis. Single use Systems for Upstream and downstream processing. Fill & Finish experience is a plus.Working knowledge if key Drug Substance manufacturing technologies such as Fermentation, Tangential Flow Filtration, ChromatographyWorking knowledge if key Drug Product manufacturing technologies such as Aseptic Filling, Isolator Technology, Automatic Visual Inspection, Label & Packaging and RoboticsDemonstrates strategic enterprise thinking, finding innovative ways to deliver results, and build trustMust possess outstanding communication, analytical, and problem-solving skills, and the ability to work with enterprise-wide information systemsAbility to interact well with other groups and must be able to take ownership of and follow through on assignments. Must be able to drive results on multiple complex assignments simultaneously with minimal required direction from his/her supervisor. Ability to represent Moderna's interests, objectives, and policies in a professional and responsible manner.Ability to make effective oral presentations and work as part of a team.Ability to represent Moderna's interests, objectives, and policies in a professional and responsible manner.Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:Highly competitive and inclusive medical, dental and vision coverage optionsFlexible Spending Accounts for medical expenses and dependent care expensesLifestyle Spending Account funds to help you engage in personal enrichment and self-care activitiesFamily care benefits, including subsidized back-up care options and on-demand tutoringFree premium access to fitness, nutrition, and mindfulness classes Exclusive preferred pricing on Peloton fitness equipmentAdoption and family-planning benefitsDedicated care coordination support for our LGBTQ+ communityGenerous paid time off, including:• Vacation, sick time and holidays• Volunteer time to participate within your community• Discretionary year-end shutdown• Paid sabbatical after 5 years; every 3 years thereafterGenerous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents 401k match and Financial Planning toolsModerna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit optionsComplimentary concierge service including home services research, travel booking, and entertainment requestsFree parking or subsidized commuter passesLocation-specific perks and extras! About ModernaSince our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.Moderna is a smoke-free, alcohol-free and drug-free work environment.Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at [email protected]. (EEO/AAP Employer) -

The Role:Our team looks forward to welcoming an experienced Bioprocess Engineer with a strong background in the regulated (bio)pharmaceutical environment supporting laboratory, pilot and commercial scale process development, mRNA technology transfer to internal and external GMP production facilities and commercial production of mRNA therapies. Our team's goal is to implement and support robust commercial manufacturing processes. This Senior Engineer role requires close working relationships with Analytical Development, Manufacturing Sciences and Technology, Manufacturing, Supply Chain, Quality, Regulatory and Program Management functions as well as with external CMO teams. The incumbent will also help develop industry skills in high-performing junior team members both at the bench and in GMP manufacturing facilities.We are establishing commercial processes that require a solid practical foundation in standard bioprocess unit operations (e.g. UF/DF, normal flow filtration, mixing systems, chromatography). The ideal candidate should have a strong background of supporting commercial operation of these unit operations with a focus on pro-active process improvements and optimization, effective troubleshooting, interfacing with existing teams to collaboratively resolve process investigations and implement appropriate controls to ensure robust commercial manufacturing. These skills should be complemented with a track record of excellent written and oral communication skills and experience operating within a Quality Management System. A history of process development and process investigation accomplishments using scaled down models, QbD-principles and process characterization/modeling techniques are strong pluses.Success in this role would be demonstrated by effective participation in process investigations, design and performance of experiments to identify/confirm associated root causes, followed by characterization and implementation of effective process changes to increase success in commercial production. This position bears the potential for significant growth in a dynamic organization.Here's What You'll Do:Provide subject matter expert (SME) expertise and representation in cross-functional process investigations for commercial processes.Support process investigations by active participation in root cause assessment exercises utilizing standard-industry toolsDesign and execute detailed experiments to assess and confirm root causes of process deviations and identify effective mitigation tools.Cross-functionally support establishment of appropriate CAPAs needed to improve robustness of commercial manufacturing processes.Identify opportunities for pro-active process improvements and optimization based on commercial performance data to improve robustness of commercial manufacturing process.Interface extensively in a matrixed environment with process development teams for process investigation support, assess new technologies, support on-going process characterization and post-approval changes.Support technology transfer and establishment of commercial process at new manufacturing sites and provide Person-in-plant (PiP) support as needed.Perform GMP activities with adherence to Quality Management System requirements.Mentor junior team members. Supervisory role may be included.Communicate clearly with program stakeholders, technical staff and external CMO partners.Generate high quality source documentation to support regulatory filings. Here's What You'll Bring to the Table:BS with a minimum of 10 years, or MS with a minimum of 8 years, or Ph.D with a minimum of 4 years of industry experience in bioprocess development and/or manufacturing sciences. Engineering-related degree preferred.Demonstrated background of providing technical support to commercial manufacturing processes, including but not limited to, support of process investigations, implementation of pro-active process modifications and support of post-approval changesExperience with mature quality management systems, deviation management, change controls and CAPA implementationExperience with lipid nanoparticle process development and mRNA process development is preferred.Experience in large molecule process development (late phase/commercial experience preferred)Knowledge of the large molecule regulatory environment, particularly FDA/ICH/ISPE guidelines on risk management, technology transfer and process validation.Strong operational skills, interdependent project/timeline management capabilities.Strong interpersonal skills with an eagerness to support colleagues across the organization and in partner organizations.Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:Highly competitive and inclusive medical, dental and vision coverage optionsFlexible Spending Accounts for medical expenses and dependent care expensesLifestyle Spending Account funds to help you engage in personal enrichment and self-care activitiesFamily care benefits, including subsidized back-up care options and on-demand tutoringFree premium access to fitness, nutrition, and mindfulness classes Exclusive preferred pricing on Peloton fitness equipmentAdoption and family-planning benefitsDedicated care coordination support for our LGBTQ+ communityGenerous paid time off, including:• Vacation, sick time and holidays• Volunteer time to participate within your community• Discretionary year-end shutdown• Paid sabbatical after 5 years; every 3 years thereafterGenerous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents 401k match and Financial Planning toolsModerna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit optionsComplimentary concierge service including home services research, travel booking, and entertainment requestsFree parking or subsidized commuter passesLocation-specific perks and extras! About ModernaSince our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.Moderna is a smoke-free, alcohol-free and drug-free work environment.Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at [email protected]. (EEO/AAP Employer) -

The RoleIn this role, you will be a key technical leader in the organization, responsible for managing complex investigations, providing drug product technical leadership, and ensuring product technical stewardship. This role requires a strong understanding of the fill-finish process, inspection, packaging, and labeling of pharmaceutical products. The ideal candidate will have a proven track record in developing product technical strategies and leading cross-functional teams to maintain product quality, efficacy, and compliance throughout the product lifecycle. Experience in new facility build-outs and new equipment qualification is highly desirable, including involvement in design, commissioning, and validation activities to ensure operational readiness for drug product manufacturing. Specific skill sets/role will include:Management of complex DP investigations: Investigation management, Root cause analysis, Risk assessment, CAPA, Documentation and Reporting, Decision-Making, Problem solving, compliance monitoringTechnical Drug Product Stewardship in support of clinical programs: Product technical strategy, engagement with technical development and manufacturing to identify solutions to complex technical challenges, product risk management, process benchmarking, technical support and troubleshooting, process development and optimization, innovation and product developmentNew equipment and facility build out: Equipment installation and commissioning, Facility design and construction, Inspection systems installation and implementation, Labeling technology and machinery set up, Packaging line design and setup for clinical and commercial, Engineering design principles, technology transfer in support of insourcing and outsourcingHere's What You'll DoLead and manage complex technical investigations to address deviations, out-of-specification results, and other product-related issues.Serve as the technical lead for drug product teams, providing strategic direction and expertise in fill-finish, inspection, packaging, and labeling operations.Assume responsibility for product technical stewardship, ensuring that all aspects of drug product manufacturing are compliant with regulatory requirements and industry best practices.Develop and implement product technical strategies that align with the company's objectives and market demands.Collaborate with cross-functional teams, including R&D, Quality, Regulatory Affairs, and Operations, to ensure seamless technology transfer and scale-up of drug products.Drive continuous improvement initiatives to enhance process robustness, increase efficiency, and reduce costs while maintaining product quality.Provide technical input during regulatory submissions and respond to questions from health authorities.Author and review technical documentation, including validation protocols, standard operating procedures (SOPs), and technical reports.Mentor and develop junior MS&T staff, fostering a culture of technical excellence and knowledge sharing.Represent the MS&T department in strategic planning discussions and provide expert guidance on technical mattersExperience in new facility build-outs and new equipment qualification is highly desirable, including involvement in design, commissioning, and validation activities to ensure operational readiness for drug product manufacturing.Here's What You'll Need (Basic Qualifications)Bachelor's or Master's degree in Chemical Engineering, Pharmaceutical Sciences, or a related scientific discipline.Minimum of 7 years of relevant experience in the biotechnology or pharmaceutical industry, with a focus on drug product manufacturing.Extensive experience managing complex technical investigations and providing technical leadership for drug products.Strong technical background in fill-finish, inspection, packaging, and labeling processes for pharmaceutical products.Demonstrated ability to develop and execute technical strategies for drug products.Excellent problem-solving skills with a systematic approach to root cause analysis.Familiarity with regulatory requirements and guidelines for pharmaceutical manufacturing (e.g., FDA, EMA, ICH).Strong leadership and communication skills, with the ability to influence and collaborate effectively with various stakeholders.Proficient in data analysis and interpretation, with a solid understanding of statistical methods.Here's What You'll Bring to the Table (Preferred Qualifications)Product technical stewardshipExperience in new facility build outA desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:Highly competitive and inclusive medical, dental and vision coverage optionsFlexible Spending Accounts for medical expenses and dependent care expensesLifestyle Spending Account funds to help you engage in personal enrichment and self-care activitiesFamily care benefits, including subsidized back-up care options and on-demand tutoringFree premium access to fitness, nutrition, and mindfulness classes Exclusive preferred pricing on Peloton fitness equipmentAdoption and family-planning benefitsDedicated care coordination support for our LGBTQ+ communityGenerous paid time off, including:• Vacation, sick time and holidays• Volunteer time to participate within your community• Discretionary year-end shutdown• Paid sabbatical after 5 years; every 3 years thereafterGenerous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents 401k match and Financial Planning toolsModerna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit optionsComplimentary concierge service including home services research, travel booking, and entertainment requestsFree parking or subsidized commuter passesLocation-specific perks and extras! About ModernaSince our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.Moderna is a smoke-free, alcohol-free and drug-free work environment.Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at [email protected]. (EEO/AAP Employer) #LI-KP1-

The RoleModerna is seeking a Principal Systems Engineer, SAP EWM to primarily support our Individualized Neoantigen Therapy (INT) unit, which is our personalized cancer technology.Reporting to the Director of the Supply Chain systems, the Principal System Engineer will support the design, development, implementation and technical support of SAP EWM across a pharmaceutical manufacturing environment. This position will play a key role in supporting the Supply Chain strategy and will collaborate cross functionally to align data, processes and technology throughout the deployment of solutions.This is a great opportunity for someone who has always wanted to have a great impact on shaping the outcome of supply chain solutions in a fast-paced pharmaceutical environment.Here's What You'll DoServe as an SAP EWM and warehouse expert to the INT team. You will use your experience in defining, designing, and configuration across SAP Extended Warehouse Management. Partner with the EWM Principal System Engineer in US to define the best design and architecture of EWM.Be the key point of contact for INT business and site for direct purchasing & warehousing departments.Support and enhance the actual EWM solution.Support data analysis, program debugging and report writing.Write business design documents, functional specs, test scripts, SOPs.Support SAP projects to drive continuous improvement for logistics activities.Perform business analysis and SAP ERP S/4 system support of the supply chain units in a fast-paced clinical and commercial drugs manufacturing environment.Here's What You'll Need (Minimum Qualifications)8+ years of experience in the design, configuration and testing of solutions across an SAP system.Specific experience in the following submodulesEWM and/or WM / HUM SAP modulesInventory management (IM)Direct Purchasing (MM)Logistics execution (LG / LE) - Intra and Intercompany stock transfersPP-PI and QMIntegration with MES and SAP EWMMultiple years of experience engaging with business partners.Experience with proposing functional solutions to developers when writing functional specs.Familiarity of SAP S/4 is a plus.Experience in an FDA regulated environment such as Pharma/Medical device.Experience with drug product serialization and serialization software is a plus.Here's What You'll Bring to the Table (Preferred Qualifications)5+ years of experience working in a GXP/Pharma/Life Science organizationExperience delivering projects using Agile MethodologySAP S/4HANA experienceAbility to manage multiple request and projects in a fast-paced environment. SAP certification preferred.Be self-driven, willing to collaborate, think creatively, and drive tasks to completion with minimal oversight.Project management skills with the ability to prioritize and multi-task activities in a dynamic, fast-paced environment and simultaneously organize work across multiple projects.A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:Highly competitive and inclusive medical, dental and vision coverage optionsFlexible Spending Accounts for medical expenses and dependent care expensesLifestyle Spending Account funds to help you engage in personal enrichment and self-care activitiesFamily care benefits, including subsidized back-up care options and on-demand tutoringFree premium access to fitness, nutrition, and mindfulness classes Exclusive preferred pricing on Peloton fitness equipmentAdoption and family-planning benefitsDedicated care coordination support for our LGBTQ+ communityGenerous paid time off, including:• Vacation, sick time and holidays• Volunteer time to participate within your community• Discretionary year-end shutdown• Paid sabbatical after 5 years; every 3 years thereafterGenerous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents 401k match and Financial Planning toolsModerna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit optionsComplimentary concierge service including home services research, travel booking, and entertainment requestsFree parking or subsidized commuter passesLocation-specific perks and extras! About ModernaSince our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.Moderna is a smoke-free, alcohol-free and drug-free work environment.Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at [email protected]. (EEO/AAP Employer) #LI-KG1-