CQV Engineer III

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.

Moderna is strengthening its presence in Marlborough Massachusetts a key hub for research development and technical operations. Our Marlborough campus advances our mRNA platform from discovery through clinical development turning promising science into real world solutions. We welcome talent committed to innovation and improving health outcomes worldwide.

In this role you will lead commissioning qualification and validation (CQV) activities to ensure facilities utilities equipment systems (FUSE) and analytical instruments remain in a qualified and compliant state within a cGMP manufacturing environment.

You will provide technical leadership drive validation strategy and serve as a subject matter expert across cross-functional and capital projects.

This is a U.S.-based individual contributor role with a full-time 5 days onsite expectation in Marlborough MA and approximately 5% travel to Norwood ensuring strong on-the-floor presence and direct engagement with manufacturing and technical operations teams.

Heres What Youll Do:

• Lead commissioning qualification and validation (CQV) activities for facilities utilities equipment systems (FUSE) and analytical instruments.

• Develop and execute validation strategies for complex systems and capital projects.

• Author and approve lifecycle validation documentation including risk assessments IQ/OQ/PQ protocols and summary reports.

• Lead deviation investigations perform root cause analysis and drive CAPA development and implementation.

• Perform and approve change control impact assessments and implementation plans to maintain validated state.

• Serve as a subject matter expert (SME) during internal and external regulatory inspections.

• Drive continuous improvement initiatives within the CQV program to enhance compliance and operational efficiency.

• Influence validation strategy and site compliance decisions through strong technical expertise.

• Lead complex or high-risk validation projects with minimal oversight.

• Provide technical mentorship to junior CQV engineers and contribute to department-level improvements.

• Independently resolve complex technical and compliance issues in alignment with validation lifecycle principles and regulatory requirements.

• Apply advanced technical writing and documentation review skills to ensure high-quality inspection-ready deliverables.

• Collaborate cross-functionally to remove barriers accelerate project execution and strengthen validation excellence.

• Leverage digital tools and data-driven approaches including exposure to advanced analytics and emerging generative AI technologies to modernize validation practices and maximize patient impact.

Heres What Youll Need (Basic Qualifications):

• Bachelor of Science in Engineering (Chemical or Mechanical preferred; other scientific disciplines considered).

• 5 years of experience in biopharmaceutical validation CQV engineering or related cGMP manufacturing roles.

• Strong understanding of validation lifecycle principles and global regulatory requirements.

• Demonstrated ability to lead complex validation efforts and capital projects.

• Advanced technical writing and documentation review skills.

• Proven ability to independently resolve complex technical and compliance issues.

• Strong cross-functional leadership and communication skills.

For this role we are currently unable to offer immigration sponsorship. Candidates must already hold work authorization in the United States and be able to maintain that status without the need for future sponsorship.

Heres What Youll Bring to the Table (Preferred Qualifications):

• Operate independently with minimal oversight.

• Lead complex or high-risk validation projects.

• Influence validation strategy and site compliance decisions.

• Mentor junior engineers and contribute to department-level improvements.

The key Moderna Mindsets youll need to succeed in the role:

We behave like owners. The solutions were building go beyond any job description.

We digitize everywhere possible using the power of code to maximize our impact on patients.

Pay & Benefits

At Moderna we believe that when you feel your best you can do your best work. Thats why our US benefits and global well-being resources are designed to support youat work at home and everywhere in between.

• Best-in-class healthcare coverage 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 planning benefits including fertility adoption and surrogacy support

• Generous paid time off including vacation volunteer days sabbatical global recharge days and a discretionary year-end shutdown

• Savings and investment opportunities to help you plan for the future

• Location-specific perks and extras

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 to learn more about our current opportunities.

Our Working Model

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.

Moderna is a smoke-free alcohol-free and drug-free work environment.

Equal Opportunities

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a persons 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 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 an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories consistent with legal requirements.

Accommodations

Were 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 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 .

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