CQV Engineer III

Moderna • Marlborough, MA

1d

About The Position

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.

Requirements

• 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.

Nice To Haves

• 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

Responsibilities

• 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.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level