Engineer II, CQV

The Role

The individual in this role supports 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 executes validation activities, authors qualification documentation, supports investigations, and collaborates cross-functionally to maintain regulatory compliance and operational readiness.

Here's What You’ll Do

• Execute commissioning, qualification, and validation (CQV) activities for FUSE and analytical instruments.

• Author and execute validation lifecycle documentation (URS support, risk assessments, IQ/OQ/PQ protocols, summary reports).

• Support deviation investigations and assist with root cause analysis and CAPA development.

• Perform change control impact assessments and support implementation plans.

• Participate on cross-functional project teams to support capital projects and site initiatives.

• Support internal and external inspections as a CQV representative.

• Ensure SOPs and validation documentation meet site and regulatory requirements.

• Utilize validation tools and equipment (e.g., data loggers such as Ellab) to support qualification activities.

Here’s What You’ll Need (Basic Qualifications)

• B.S. in Engineering (Chemical, Mechanical are preferred; other related scientific disciplines will be considered).

• 2–5 years of CQV or validation experience in cGMP manufacturing environments.

• Working knowledge of validation lifecycle principles and regulatory expectations.

• Ability to author and review technical documentation in compliance with site procedures.

• Structured problem-solving skills with ability to support root cause investigations.

• Strong communication skills with ability to collaborate across Engineering, Facilities, Operations, Automation, and QA.

• Add this under the BQ section: This position is site-based, requiring you to be at Moderna’s site full-time. This position is not eligible for remote work.

• 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)

• Works independently on routine to moderately complex validation activities.

• Receives guidance on complex or high-risk projects.

• Contributes to continuous improvement initiatives within the CQV program.

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 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 investments 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. 

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