CQV Engineer III

BioSpace; Marlborough (MA); On-site; USD 89,900 - 143,800; Full time

Benefits offered by this job

Best-in-class healthcare coverage

Holistic well-being support

Generous paid time off

Savings and investment opportunities

Job summary

A leading biotech company in Marlborough, MA, is seeking an individual contributor to lead commissioning, qualification, and validation (CQV) activities in a cGMP environment. The ideal candidate will have a Bachelor of Science in Engineering and over 5 years of experience in biopharmaceutical validation. Responsibilities include developing validation strategies, leading projects, and collaborating cross-functionally. Competitive salary range of $89,900.00 - $143,800.00, with excellent benefits, including healthcare and generous paid time off.

Qualifications

• 5+ years of experience in biopharmaceutical validation or related roles.
• Strong understanding of global regulatory requirements.
• Demonstrated ability to lead complex validation efforts.

Responsibilities

• Lead CQV activities for facilities, utilities, and analytical instruments.
• Develop and execute validation strategies for projects.
• Serve as SME during regulatory inspections.

Skills

Validation lifecycle principles

Technical writing

Cross-functional leadership

Problem-solving

Education

Bachelor of Science in Engineering

Job description

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.

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.

What You’ll 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.

What You’ll 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.

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 you’ll need to succeed in the role

We behave like owners. The solutions we’re building go beyond any job description.

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

Pay & Benefits

• 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

The salary range for this role is $89,900.00 - $143,800.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual’s position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs. The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance.

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 be 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 [e-mail].

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.