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. Here’s 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. Here’s 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. 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. Here’s What You’ll 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 ... (truncated, view full listing at source)