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Plant Engineer III
ModernaTX, Inc., Norwood
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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! 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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-
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) -
Process Maintenance Technician III, 3rd Shift Sun-Wed
ModernaTX, Inc., Norwood
The Role:Based at our new cGMP Manufacturing facility in Norwood, MA, this position will be responsible for maintenance and repairs of GMP/non-GMP process systems and support equipment. This position will also support troubleshooting, investigations, and reliability engineering for GMP/non-GMP process and support equipment. This position will be the first responder to equipment issues and must follow through to ensure resolution by either self-performing the work or directing the activities of service providersHere's What You'll Do:Perform preventative and corrective maintenance activities to support process equipment and systems, in accordance with established procedures and/or approved practices. Support efforts in developing remediation for follow-up and emergency work.Troubleshoot equipment and systems, and repair malfunctioning equipment. Work with equipment owners/engineers and direct the performance of work by equipment vendors.Maintain cGMP records, both paper-based and electronic.Understand Asset Management and routine reliability concepts.Provide subject matter expertise for the operation and maintenance of manufacturing and support systems/equipment such as Process Air, Process Chilled Water, Nitrogen, Water for Injection (WFI) generation and distribution systems, autoclaves, washers, TFF, Chromatography Columns and skids, mixers, and stainless tanks. Maintain Facilities SOPs as required. Perform revisions and maintain author/owner responsibilities.Provide "on-call" support on a rotating basis. Support regular 24-7 operation of facility and respond to facilities issues as needed.Ensure that spare parts, tools, calibration standards and equipment are available to complete all assigned tasks.Respond to alarms and document activities in accordance with cGMP requirements. Working with equipment owners and develop remediation activities for alarms. Manage contract service providers; including scheduling, training on required SOP's, coordination and ensuring all work and documentation is performed in accordance with cGMP requirements.Administer and perform hazardous energy control procedures and confined space entry. Other duties as required.Here's What You'll Bring to the Table:AS or BS degree in a science/technical field or a technical trade school preferred with 5-8 years of relevant experience working in a regulated (cGMP preferred) environment.Thorough understanding of OSHA regulations related to LOTO, MSDS, Confined Space and Hot Work.Military training equivalent of above is acceptable.Experience with Metrology.Understanding of PLC controls for simple troubleshooting is preferred.Excellent interpersonal and communication skills (verbal and written) are required. Ability to present own work to peers and cross-functional managers and influence leadership decisions.Technical writing skills required.Must have a customer service mindset.Must be able use technical expertise and judgement to investigate issues using a structured problem-solving approach t3o determine true root cause and path forward for complex problems. Demonstrated ability to learn new equipment/systems.Familiarity with Excel, Word, and PowerPoint.Ability to navigate computerized data and information management systems.Ability to interact well with other groups and must be able to take ownership of and follow through on assignments with minimal guidance. Must be able to drive results on multiple assignments simultaneously with minimal direction from management. Ability to represent Moderna's interests, objectives, and policies in a professional and responsible manner.Ability to work in fast-paced manufacturing environment.Respect for People.Ability to work collaboratively.Creative Problem Solving.Decision Making.Exemplary Work Ethic, Driven by the Mission.Impeccable Integrity.Risk Taking / Accountability.Humility.Mental Toughness.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-NB1-
Technician IV, Facilities (1st shift, Sun-Wed)
ModernaTX, Inc., Norwood
The RoleIn this role, you will perform preventative and corrective maintenance activities to support process equipment and systems, in accordance with established procedures and/or approved practices. Support efforts in developing remediation for follow-up and emergency work.Here's What You'll DoTroubleshoot equipment and systems, and repair malfunctioning equipment. Work with equipment owners/engineers and direct the performance of work by equipment vendors.Maintain cGMP records, both paper-based and electronic.Understand Asset Management and routine reliability concepts.Provide subject matter expertise for the operation and maintenance of manufacturing and support systems/equipment such as Process Air, Process Chilled Water, Nitrogen, Water for Injection (WFI) generation and distribution systems, autoclaves, washers, TFF, Chromatography Columns and skids, mixers, and stainless tanks. Maintain Facilities SOPs as required. Perform revisions and maintain author/owner responsibilities.Provide "on-call" support on a rotating basis. Support regular 24-7 operation of facility and respond to facilities issues as needed.Ensure that spare parts, tools, calibration standards and equipment are available to complete all assigned tasks.Respond to alarms and document activities in accordance with cGMP requirements. Working with equipment owners and develop remediation activities for alarms. Manage contract service providers; including scheduling, training on required SOP's, coordination and ensuring all work and documentation is performed in accordance with cGMP requirements.Administer and perform hazardous energy control procedures and confined space entry. Other duties as required.Here's What You'll Need (Minimum Qualifications)AS or BS degree in a science/technical field or a technical trade school preferred with 7-10 years of relevant experience working in a regulated (cGMP preferred) environment.Military training equivalent of above is acceptable.Here's What You'll Bring to the Table (Preferred Qualifications)Thorough understanding of OSHA regulations related to LOTO, MSDS, Confined Space and Hot Work.Experience with Metrology.Understanding of PLC controls for simple troubleshooting is preferred.Excellent interpersonal and communication skills (verbal and written) are required. Ability to present own work to peers and cross-functional managers and influence leadership decisions.Technical writing skills required.Must have a customer service mindset.Must be able use technical expertise and judgement to investigate issues using a structured problem-solving approach t3o determine true root cause and path forward for complex problems. Demonstrated ability to learn new equipment/systems.Familiarity with Excel, Word, and PowerPoint.Ability to navigate computerized data and information management systems.Ability to interact well with other groups and must be able to take ownership of and follow through on assignments with minimal guidance. Must be able to drive results on multiple assignments simultaneously with minimal direction from management. Ability to represent Moderna's interests, objectives, and policies in a professional and responsible manner.Ability to work in fast-paced manufacturing environment.Respect for People.Ability to work collaboratively.Creative Problem Solving.Decision Making.Exemplary Work Ethic, Driven by the Mission.Impeccable Integrity.Risk Taking / Accountability.Humility.Mental Toughness.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-NB1-
Sr. Business Process Manager, Digital Quality
ModernaTX, Inc., Norwood
The RoleIn this role, you will report to and work closely with the Director, Digital Quality to design, deploy and manage our expanding portfolio of digital quality management systems that support Quality and batch release processes. This role will help shape and deliver the long-term strategic vision for the Quality QMS Digital roadmap. This opportunity is unique in the pace and speed we expect and achieve.Who You Are:You are passionate about quality, continuous improvement, and enhancing systems to ensure optimal user experience and business efficiency. A master integrator gifted in bringing together people, concepts, and business goals with best-in-class execution. You thrive in a fast-paced environment and are comfortable rolling up your sleeves - if a process doesn't exist yet, you define it. You collaborate well amongst a team of expert peers.Here's What You'll DoDrive the execution of complex projects - proactively identifying risks / mitigation strategies while communicating to stakeholders and driving timelines through a blend of project management, technology, and business process expertise.Execute on our Digital Quality strategy with clear communication, prioritization, and escalation, both within Digital Quality and other cross functional teamsMentor a team of internal and external business analysts and software engineers designing, implementing, and maintaining our electronic quality management system, Veeva QualityPartner with digital stakeholders to ensure successful planning and integration of key systems into the quality management system while looking out for automation capabilities, and any artificial intelligence initiatives.Foster a culture of innovation within the team and with stakeholders to challenge the status quo leveraging both new technologies and creative solutions within existing systems.Support the Digital Quality Leadership Team by managing action plans and project plans to deliver short-, mid-, and long-term quality goals.Apply an operational excellence mindset to help Identify, devise, and recommend new opportunities to optimize current processes.Define and deliver a consistent systems governance methodology across applications with clear roles and responsibilities established throughout the system lifecycle: Implementation, Enhancement, and SupportEnsure GxP compliance is built into the design, delivery, and maintenance of all systems.Maintain inspection readiness through adherence to internal quality policies, procedures, and training.Participate in internal and external audits as digital quality expert for portfolio of processes.Hit the ground running immediately and work closely with various stakeholders in Quality to enable sustainable commercial operations.Here's What You'll Need (Minimum Qualifications)Bachelor's degree in science, technology, or another relevant academic discipline8-10 years of experience designing implementing and maintaining electronic quality management systems to support compliance processes in a regulated biotech or Pharma company.Experience with GAMP and GxP compliance regulationsHere's What You'll Bring to the Table (Preferred Qualifications)Strong understanding of batch release, quality management workflows, and related processesDemonstrated experience defining, scoping, and managing technology initiatives; exceptional skills at facilitating teams and building consensus with membership comprised of diverse levels and areas of the company.Proficient in relevant project management software: Smartsheet, Excel, PowerPoint, Word, OneNote, MS Teams, etc. in addition to general knowledge with shared work environmentsPeople-orientedExtremely organized.Creative/innovative/problem solver that actively drives progress.Passion for people management and development in matrix teamsOutstanding communication, presentation, and writing skills and ability to tailor messaging to audience.Ability to manage multiple projects in a fast-paced environment.Ability to effectively collaborate in a dynamic, cross-functional matrix environment.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-
Technician IV, Facilities, 1st Shift Sun-Wed
ModernaTX, Inc., Norwood
The RoleIn this role, you will perform preventative and corrective maintenance activities to support process equipment and systems, in accordance with established procedures and/or approved practices. Support efforts in developing remediation for follow-up and emergency work.Here's What You'll DoTroubleshoot equipment and systems, and repair malfunctioning equipment. Work with equipment owners/engineers and direct the performance of work by equipment vendors.Maintain cGMP records, both paper-based and electronic.Understand Asset Management and routine reliability concepts.Provide subject matter expertise for the operation and maintenance of manufacturing and support systems/equipment such as Process Air, Process Chilled Water, Nitrogen, Water for Injection (WFI) generation and distribution systems, autoclaves, washers, TFF, Chromatography Columns and skids, mixers, and stainless tanks. Maintain Facilities SOPs as required. Perform revisions and maintain author/owner responsibilities.Provide "on-call" support on a rotating basis. Support regular 24-7 operation of facility and respond to facilities issues as needed.Ensure that spare parts, tools, calibration standards and equipment are available to complete all assigned tasks.Respond to alarms and document activities in accordance with cGMP requirements. Working with equipment owners and develop remediation activities for alarms. Manage contract service providers; including scheduling, training on required SOP's, coordination and ensuring all work and documentation is performed in accordance with cGMP requirements.Administer and perform hazardous energy control procedures and confined space entry. Other duties as required.Here's What You'll Need (Minimum Qualifications)AS or BS degree in a science/technical field or a technical trade school preferred with 7-10 years of relevant experience working in a regulated (cGMP preferred) environment.Here's What You'll Bring to the Table (Preferred Qualifications)Thorough understanding of OSHA regulations related to LOTO, MSDS, Confined Space and Hot Work.Military training equivalent of above is acceptable.Experience with Metrology.Understanding of PLC controls for simple troubleshooting is preferred.Excellent interpersonal and communication skills (verbal and written) are required. Ability to present own work to peers and cross-functional managers and influence leadership decisions.Technical writing skills required.Must have a customer service mindset.Must be able use technical expertise and judgement to investigate issues using a structured problem-solving approach t3o determine true root cause and path forward for complex problems. Demonstrated ability to learn new equipment/systems.Familiarity with Excel, Word, and PowerPoint.Ability to navigate computerized data and information management systems.Ability to interact well with other groups and must be able to take ownership of and follow through on assignments with minimal guidance. Must be able to drive results on multiple assignments simultaneously with minimal direction from management. Ability to represent Moderna's interests, objectives, and policies in a professional and responsible manner.Ability to work in fast-paced manufacturing environment.Respect for People.Ability to work collaboratively.Creative Problem Solving.Decision Making.Exemplary Work Ethic, Driven by the Mission.Impeccable Integrity.Risk Taking / Accountability.Humility.Mental Toughness.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-NB1-
Technician III, Facilities Management
ModernaTX, Inc., Norwood
The RoleBased at our new cGMP Manufacturing facility in Norwood, MA, this position will be responsible for calibration, maintenance, and repairs of GMP/non-GMP process systems and support equipment. This position will also support troubleshooting, investigations, and reliability engineering for GMP/non-GMP process and support equipment. This position will be the first responder to equipment issues and must follow through to ensure resolution by either self-performing the work or directing the activities of service providers.Here's What You'll DoPerform preventative and corrective maintenance activities and calibrations to support process equipment and systems, in accordance with established procedures and/or approved practices. Support efforts in developing remediation for follow-up and emergency work.Troubleshoot equipment and systems, and repair malfunctioning equipment. Work with equipment owners/engineers and direct the performance of work by equipment vendors.Maintain cGMP records, both paper-based and electronic.Understand Asset Management and routine reliability concepts.Provide subject matter expertise for the operation and maintenance of manufacturing and support systems/equipment such as Process Air, Process Chilled Water, Nitrogen, Water for Injection (WFI) generation and distribution systems, autoclaves, washers, TFF, Chromatography Columns and skids, mixers, and stainless tanks. Perform calibrations in the following disciplines: Balances/scales, flow, temperature, conductivity, pressure, and UV among others in a GMP/GXP environment.Maintain Facilities SOPs as required. Perform revisions and maintain author/owner responsibilities.Provide "on-call" support on a rotating basis. Support regular 24-7 operation of facility and respond to facilities issues as needed.Ensure that spare parts, tools, calibration standards and equipment are available to complete all assigned tasks.Respond to alarms and document activities in accordance with cGMP requirements. Working with equipment owners and develop remediation activities for alarms. Manage contract service providers; including scheduling, training on required SOP's, coordination and ensuring all work and documentation is performed in accordance with cGMP requirements.Administer and perform hazardous energy control procedures and confined space entry. Other duties as required.Here's What You'll Need (Minimum Qualifications)AS or BS degree in a science/technical field or a technical trade school preferred with 5-8 years of relevant experience working in a regulated (cGMP preferred) environment.Here's What You'll Bring to the Table (Preferred Qualifications)Thorough understanding of OSHA regulations related to LOTO, MSDS, Confined Space and Hot Work.Military training equivalent of above is acceptable.Experience with Metrology.Understanding of PLC controls for simple troubleshooting is preferred.Excellent interpersonal and communication skills (verbal and written) are required. Ability to present own work to peers and cross-functional managers and influence leadership decisions.Technical writing skills required.Must have a customer service mindset.Must be able use technical expertise and judgement to investigate issues using a structured problem-solving approach t3o determine true root cause and path forward for complex problems. Demonstrated ability to learn new equipment/systems.Familiarity with Excel, Word, and PowerPoint.Ability to navigate computerized data and information management systems.Ability to interact well with other groups and must be able to take ownership of and follow through on assignments with minimal guidance. Must be able to drive results on multiple assignments simultaneously with minimal direction from management. Ability to represent Moderna's interests, objectives, and policies in a professional and responsible manner.Ability to work in fast-paced manufacturing environment.Respect for People.Ability to work collaboratively.Creative Problem Solving.Decision Making.Exemplary Work Ethic, Driven by the Mission.Impeccable Integrity.Risk Taking / Accountability.Humility.Mental Toughness.A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.This position is site-based, requiring you to be at Moderna's site full-time. This position is not eligible for remote work.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-NB1-