The Role Joining Moderna means advancing mRNA science to transform medicine. Work with exceptional global teams on a broad pipeline and build a career that makes a real difference for patients. This individual-contributor role provides technical engineering leadership and hands-on support for commissioning, qualification, validation readiness, and routine GMP manufacturing operations within Drug Product Fill & Finish at Clayton. You will serve as a critical technical interface between Commissioning, Qualification & Validation (CQV) and Drug Product Engineering, supporting the qualification, operational readiness, reliability, and lifecycle management of filling lines, autoclaves, parts washers, and associated process systems. Combining engineering expertise, cGMP knowledge, independent technical judgment, and cross-functional problem-solving, you will help ensure equipment performance, manufacturing readiness, regulatory compliance, and continuous improvement throughout the equipment lifecycle. Here’s What You’ll Do Support commissioning, qualification, and validation activities for GMP Drug Product manufacturing equipment, including filling lines, autoclaves, parts washers, and associated process systems. Coordinate equipment qualification activities from preparation through execution and closeout, including qualification protocol preparation, execution support, technical assessments, documentation review, and resolution of qualification-related issues. Support Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities, as applicable to assigned equipment and projects. Serve as technical system owner for assigned Drug Product manufacturing equipment, ensuring continued operational readiness, equipment reliability, lifecycle performance, and compliance with GMP requirements. Provide day-to-day engineering support for aseptic Fill & Finish manufacturing operations, troubleshooting equipment and process-system issues and providing technical direction for investigations and resolution. Serve as a technical interface between CQV and Drug Product Engineering, ensuring qualification activities remain aligned with manufacturing requirements, operational priorities, project schedules, and regulatory expectations. Coordinate engineering and qualification priorities to support manufacturing schedules, equipment readiness, operational continuity, and critical project milestones. Support Process Performance Qualification (PPQ), aseptic process simulations, including media fills, and manufacturing scale-up activities. Lead and support equipment-readiness assessments, qualification impact assessments, and technical risk evaluations associated with Drug Product manufacturing systems. Support first-air protection initiatives and identify engineering improvements associated with aseptic processing, equipment design, and protection of critical processing environments. Coordinate temperature-mapping studies and associated qualification activities in collaboration with Validation, Engineering, and Facilities. Partner closely with Manufacturing, Maintenance, Automation, Validation, Quality, and Facilities to troubleshoot equipment issues, assess technical risks, and develop appropriate remediation strategies. Support equipment modifications, engineering changes, and return-to-service activities, evaluating potential impacts to equipment qualification, validated processes, and ongoing manufacturing operations. Support and own Change Controls, CAPAs, and Deviations as assigned, including technical investigations, impact assessments, root-cause evaluation where applicable, and implementation of corrective actions. Ensure compliance with GMP requirements and associated controlled documentation, including SOPs, qualification protocols, technical reports, equipment records, and engineering assessments. Maintain accurate, complete, and inspection-ready cGMP records, both paper-based and electronic, in accordance with Moderna's Quality System. Provide technical expertise for assigned Drug Product manufacturing equipment and support equipment lifecycle management from initial qualification and operational readiness through routine GMP manufacturing operations. Partner with Maintenance and Facilities to support preventative and corrective maintenance activities, strengthen equipment reliability, and maintain operational readiness. Identify and implement continuous-improvement opportunities related to equipment performance, qualification execution, manufacturing efficiency, operational reliability, and engineering ways of working. Coordinate cross-functional Engineering and CQV activities, ensuring alignment of technical deliverables, qualification execution, project schedules, resources, and manufacturing priorities. Lead assigned engineering projects and qualification workstreams as an individual contributor, providing technical direction and coordinating cross-functional resources to support safe, compliant, and timely execution. Support the scheduling and planning of engineering, qualification, and manufacturing-readiness activities. Collaborate with equipment vendors and service providers to support technical assessments, equipment troubleshooting, qualification activities, maintenance needs, and resolution of equipment-related issues. Provide technical input into equipment specifications, engineering assessments, qualification strategies, system improvements, and equipment optimization initiatives. Support regulatory, partner, and internal audits by providing technical documentation, equipment qualification records, engineering assessments, and subject-matter expertise for assigned systems. Apply independent engineering judgment to identify technical and compliance risks, prioritize activities, evaluate options, and recommend solutions that protect equipment compliance and continuity of manufacturing operations. Support knowledge transfer and provide technical guidance to engineering colleagues, qualification personnel, manufacturing stakeholders, and other cross-functional partners as appropriate. Look for opportunities to work with Generative AI and other digital tools to accelerate technical knowledge retrieval, support engineering analysis, strengthen troubleshooting workflows, and improve the efficiency of documentation and equipment-lifecycle activities, while operating within Moderna's applicable quality, data, and compliance requirements. Perform other duties as required in support of Clayton Drug Product manufacturing operations. The key Moderna Mindsets you’ll need to succeed in the role: “We act with dynamic range, driving strategy and execution at the same time at every step.” “We behave like owners. The solutions we’re building go beyond any job description.” Here’s What You’ll Need (Basic Qualifications) Education: Bachelor's degree in Chemical Engineering, Mechanical Engineering, Biomedical Engineering, or a related engineering discipline. Experience: 10+ years of relevant experience in pharmaceutical or biotechnology manufacturing, Drug Product Engineering, Commissioning, Qualification & Validation, or a related technical field. Specific Certifications or Training: Working knowledge of cGMP requirements, equipment qualification practices, validation lifecycle principles, and pharmaceutical manufacturing quality systems. Familiarity with IQ/OQ/PQ, change controls, deviations, CAPAs, and GMP documentation requirements. Other Quantifiable Preference: Experience supporting aseptic Fill & Finish manufacturing equipment, including filling lines, autoclaves, parts washers, and associated process systems. Experience with PPQ readiness, media fills, temperature mapping, equipment qualification, manufacturing technical support, and cross-functional project execution preferred. Our Working Model As we build our company, we have always believed that an in-person culture is critical to our success. This role is 100% onsite, reflecting the importance of being physically present to support the work, collaborate closely with colleagues, and contribute to our site-based operations. Working onsite enables real-time collaboration, strong team connections, direct mentorship, and the hands-on partnership needed to deliver our mission. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact. Moderna is a smoke-free, alcohol-free, and drug-free work environment. Pay & Benefits At Moderna, we believe that when you feel your best, you can do your best work. That’s why our benefits and well-being resources are designed to support you—at work, at home, and everywhere in between. Competitive healthcare, plus voluntary benefit programs to support your unique needs A holistic approach to well-being with access to fitness, mindfulness, and mental health support Family building benefits, including fertility, adoption, and surrogacy support Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown Savings and investments to help you plan for the future Location-specific perks and extras The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work. About Moderna Since 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. 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 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 committed to equal opportunity in employment 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. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. We’re focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best. Moderna is committed to offering reasonable accommodation or adjustments to qualified job applicants with disabilities. Any applicant requiring an accommodation or adjustment 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 and Adjustments team at [email protected]. - Our Mission and Vision At Moderna we are pioneering the development of a new class of drugs made of messenger RNA (mRNA). This novel drug platform builds on the discovery that modified mRNA can direct the body’s cellular machinery to produce nearly any protein of interest, from native proteins to antibodies and other entirely novel protein constructs that can have therapeutic activity inside and outside of cells. We have a clear mission to propel the field of mRNA science forward and deliver new medicines to patients and a unique vision for how to achieve this mission. Our Mission: To deliver on the promise of transformative messenger RNA (mRNA) science to bring new medicines to patients. Our Vision: To unlock the potential of mRNA by establishing an ecosystem of teams and partners that will work together to develop the broadest possible array of drugs, across diverse therapeutic areas and routes of administration, for serious diseases that are not treatable today. Third Party Staffing Agencies Moderna does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to Moderna from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Moderna and do not obligate Moderna to pay fees if we hire from those resumes. Reasonable Accommodation Notice Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act and certain state or local laws. Please inform the company's personnel representative by calling 617-460-9346 or emailing [email protected] if you need assistance completing any forms or to otherwise participate in the application process. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment. Return Home

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