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Engineer III, Systems Integration
ModernaTX, Inc., Norwood
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) -
Sr. Engineer I, Automated Systems Engineering
ModernaTX, Inc., Norwood
The RoleModerna is looking for a Senior Engineer I to join the Automated Systems Engineering team at our site in Norwood MA. The person in this role will work on the development, demonstration, and delivery of projects related to automated systems, help with documentation, and act as an SME in cross-functional teams. This role will have a significant impact across our organization by enabling cross-functional cooperation between teams that support our technical development and technical operations organizations. The successful candidate will be a key player during the design, build, test, deploy, and continuous improvement stages of key automated systems. This is a chance to be part of a progressive team and to make a difference in life-changing technologies.Here's What You'll Do:Collaborate with scientists to adapt bench top workflows to semi and fully automated workflows through requirement gathering, scripting, and deployment of liquid handlers and integrated automation platforms.Lead efforts to successfully deploy custom designed equipment for use in a pre-clinical, GLP, and GMP environments.Leverage your technical expertise to help shape our digital transformation by partnering with Digital and Systems Integration teams to integrate automation into our computational and data infrastructure.Prepare detailed development documents and provide hands-on training to operators allowing for successful handoff of automation platforms.Provide method development and troubleshooting support for existing automation workflows.Evaluate new automation to introduce cutting edge technologies to the team and wider organization.Follow engineering best practices to create robust lab automation infrastructure.Employ robust version control during method development.Act as a mentor for junior engineers, fostering a culture of learning and growth.Here's What You'll Need (Minimum Qualifications)BS in molecular biology, computer engineering/science, bioengineering or similar with 5+ years laboratory automation experience.Experience programming and developing with laboratory automation software/hardware and liquid handlers.Ability to routinely lift up to 15 lb. and occasionally up to 45 lb.Here's What You'll Bring to the Table (Preferred Qualifications)M.S. in STEM or a related field with 5+ years experience in a relevant industry or Phd with academic experience in a related field.Experience fully integrating automation hardware into data infrastructure, scheduling software, cloud infrastructure, and/or analytics software.Experience with 3rd party automation hardware such as decappers, centrifuges, dispensers, sealers/peelers, etc.Experience in DoE experimental design and method development.Experience with sample storage automation such as Liconic or Hamilton storage.Direct experience configuring and optimizing Hamilton STAR/Vantage automated liquid handling systems.Experience with LIMS systems and ELN such as Benchling and LabVantage.Experience with Bitbucket/GIT version control tools.Hands-on lab experience in one of the following areas: DNA assembly, plasmid creation and amplification, analytical assay development for DNA/RNA, and NGS.Experience with scheduling software such as Cellario, Green Button Go, Momentum, etc.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-
Sr. Engineer II, Process Development
ModernaTX, Inc., Norwood
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) -
Process Engineer III
ModernaTX, Inc., Norwood
The Role:The Process Engineer will serve as a Technical Lead for Capital projects, overseeing GMP manufacturing process equipment at the Moderna manufacturing facility in Norwood, MA. This individual will collaborate closely with MS&T, Facilities, Validation, and equipment End Users to successfully drive projects to completion. The ideal applicant will thrive in a fast-paced, dynamic, and innovative environment, and will play a critical role with ensuring that their projects are executed efficiently and effectively to meet objectives and timelines.Here's What You'll Do:Provide direct engineering support and Subject Matter Expertise for process equipment in use at Norwood, MA (Ultrafiltration, Chromatography, Mixing Systems, Single Use Mixers, Buffer Prep Vessels, Temperature Control Units, Fermenters, Reaction Vessels, etc.).Drive results by owning and completing medium to large sized projects with challenging timelines and complex subject matter. 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. The Process Engineer will participate on 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.Own quality records such as Change Controls, Deviations, and CAPAs, related to manufacturing process equipment, as required. Provide input into preventative maintenance plans, assessing Change Controls, and continuous improvement initiatives.Maintain Engineering Turnover Packages, including specifications, component lists, operating manuals, and drawings for GMP process equipment.Here's What You'll Bring to the Table:A bachelor's degree in Chemical or Mechanical EngineeringMinimum of 4-7 years relevant experience as a Process Engineer2 years of experience in a GxP environment preferredExperience with Bioprocess Equipment (Ultrafiltration, Chromatography, TMIX, Single Use Mixers, Buffer Prep Vessels, Temperature Control Units, Fermenters, Reaction Vessels, etc.)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 root cause and develop effective corrective and preventative actions. Must be able to be able to find root cause and path forward for complex problems. Familiarity with Microsoft 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.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-DS1-
Senior Engineer, GXP Systems
ModernaTX, Inc., Norwood
The RoleThe Senior Engineer is responsible for the successful delivery of digital manufacturing (Batch) reports at Moderna. This role requires a combination of software development and understanding of manufacturing processes and GxP regulations to develop and maintain batch reports that are critical to the production of Moderna products.Here's What You'll DoDefine the product vision, strategy, and roadmap, ensuring alignment with company objectives and customer needsPrioritize product features and lead cross-functional teams to deliver high-quality productsOversee or develop user requirements, functional specifications, and detailed design for user applications in a fast-paced, dynamic environment.Serve as the primary communicator and advocate for the product, liaising between stakeholders, customers, and development teamsObsess over customer problems, relentlessly pursuing solutions to drive meaningful outcomesCollaborate with end users and software developers to ensure deliverables meet expectations.Develop GxP documentation and test protocols to ensure compliance and quality.Here's What You'll Need (Minimum Qualifications)B.S. in Engineering or Computer Science with minimum 5+ years of experience.In-depth knowledge of Infobatch (Informetric Systems) for developing sophisticated batch reports in a GxP environment is essential.Experience in developing and managing software platforms using an Agile methodology.Here's What You'll Bring to the Table (Preferred Qualifications)Quickly learn new skills and technologies.Excellent communication skills with the ability to work effectively with cross-functional teams at varying organizational levels.Ability to manage multiple tasks concurrently, prioritize effectively, and work in a multi-disciplinary team.Knowledge of integration technologies such as Web Services, API, XML, JSON and ETL tools such as HighByte, RDBMS (SQL, triggers, stored procedures) and troubleshooting.Knowledge of messaging schemas such as OAGIS, B2MML.Knowledge of Graph Databases and GraphQL API.Knowledgeable in FDA validation requirements.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) -
Engineer II, Manufacturing Process Engineer
ModernaTX, Inc., Norwood
The RoleIn this role, you will be responsible for supporting the day-to-day operations of our cutting-edge manufacturing processes at Norwood. This role will be instrumental in reducing manufacturing events, minimizing user interventions, and enhancing product quality and safety standards through direct engineering support, troubleshooting acumen, and continuous improvement initiatives. Your expertise will not only ensure the smooth and efficient production of our products but also drive the innovation and optimization of our manufacturing space. Applicants should have a blend of technical expertise, problem-solving skills, and a collaborative spirit to support our mission and contribute to our growth in a fast-paced, multiproduct environment.Here's What You'll DoProvide direct engineering support for process equipment in use at Norwood, MA (Ultrafiltration, Chromatography, TMIX, Single Use Mixers, Buffer Prep Vessels, Temperature Control Units, Fermenters, Reaction Vessels, etc...) to reduce manufacturing events, user interventions and batch record alerts.Manufacturing Support: Assist in the setup/ changeover of manufacturing systems and processes. Provide hands-on support to ensure equipment and machinery are functioning optimally. Perform operational assessments to ensure procedures and tools are in place.Troubleshooting & Triage: Act as the first point of contact for any manufacturing issues. Quickly diagnose and resolve technical problems independently to minimize downtime. Determine root cause of failure modes, with support from Process Engineering System Owners for more complex issues.Automated Method Updates: Responsible for all automated method updates of processing equipment in the manufacturing space. This includes developing and implementing updates for both new product introductions and enhancements to existing product functionalities, ensuring seamless integration and minimal disruption to ongoing operations.Process Optimization: Continuously monitor production processes to identify improvements that increase efficiency, reduce waste, and improve quality and support continuous improvement efforts with Process Engineering System Owners.Documentation: Meticulously document all activities related to manufacturing setup, troubleshooting, and triaging, and automated method updates per applicable SOPs and guidelines.Quality: Work closely with the Quality Assurance team to ensure that all manufacturing processes meet internal and external regulatory requirements via support of deviation initiation, CAPAs and out-of-tolerance investigations related to instrument calibrations.Training: Provide training and guidance to manufacturing staff on new equipment, processes, and troubleshooting techniques. Drive learning between MFG and F&E.Safety Compliance: Ensure all manufacturing activities are conducted in accordance with health, safety, and environmental regulations.On-Call: Support the process engineering on call team and provide updated guidelines for troubleshooting.Additional duties as may be assigned from time to time.Here's What You'll Need (Minimum Qualifications)Minimum Education Requirement: A bachelor's degree in chemical engineering, mechanical engineering, or related field.Minimum of 2 years of relevant experience as a Process Engineer, Manufacturing Engineer, or related role.Here's What You'll Bring to the Table (Preferred Qualifications)Minimum of 2 years of experience in a GMP environment preferred.Experience with Bioprocess Equipment (Ultrafiltration, Chromatography, TMIX, Single Use Mixers, Buffer Prep Vessels, Temperature Control Units, Fermenters, Reaction Vessels, etc)Strong analytical and problem-solving skills.Ability to excel in a fast paced, multiproduct environment.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.Demonstrated ability to manage own time and deliver to program timelines.Proven ability to multitask.Self-directed with effective analytical and problem-solving skills. Must be able to deliver results on multiple complex assignments simultaneously in a fast-paced environment.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. Familiarity 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.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-DS1-