The Role
The individual in this role leads commissioning, qualification, and validation (CQV) activities to ensure facilities, utilities, equipment, systems (FUSE), and analytical instruments remain in a qualified and compliant state within cGMP manufacturing environments.
This role provides technical leadership, drives validation strategy, supports complex investigations, and serves as a subject matter expert (SME) across cross-functional and capital projects.
Here's What You’ll Do
Lead commissioning, qualification, and validation (CQV) activities for FUSE and analytical instruments.
Develop and execute validation strategies for complex systems and capital projects.
Author and approve lifecycle validation documentation (risk assessments, IQ/OQ/PQ, summary reports).
Lead deviation investigations, root cause analysis, and CAPA development.
Perform and approve change control impact assessments and implementation plans.
Provide technical oversight and mentorship to junior CQV engineers.
Serve as SME during internal and external regulatory inspections.
Drive continuous improvement initiatives within the CQV program.
Here’s What You’ll Need (Basic Qualifications)
B.S. in Engineering (Chemical, Mechanical are preferred; other scientific disciplines will be considered).
5+ years of experience in biopharmaceutical validation, CQV, engineering, or related cGMP manufacturing roles.
Strong understanding of validation lifecycle principles and 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.
At Moderna, we are focused on delivering on our mission by enabling talent to thrive. For this role, we are currently unable to offer immigration sponsorship. Candidates must already hold work authorization in US and be able to maintain that status without the need for future sponsorship.
Here’s What You’ll Bring to the Table (Preferred Qualifications)
Operate independently with minimal oversight.
Leads complex or high-risk validation projects.
Influences validation strategy and site compliance decisions.
Mentors junior engineers and contributes to department-level improvements
Pay & Benefits
At Moderna, we believe that when you feel your best, you can do your best work. That’s why our US benefits and global well-being resources are designed to support you—at 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 modernatx.com/careers 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 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 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
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 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 leavesandaccommodations@modernatx.com.
Export Control Notice This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant’s ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license. #LI-NB1-