CQV Engineer II

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 Norwood, Massachusetts, a cornerstone of our manufacturing and operational excellence. Our Norwood campus translates mRNA science into scalable impact, supporting the global delivery of our medicines. We welcome talent ready to drive innovation and make a meaningful difference for patients worldwide. In this role, you will support 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 execute validation lifecycle activities, author technical documentation, and collaborate cross-functionally to maintain regulatory compliance and operational readiness. This is a highly technical, site-based role embedded within our manufacturing ecosystem, ensuring infrastructure performance meets the highest quality and regulatory standards. Here’s What You’ll Do: Execute commissioning, qualification, and validation (CQV) activities for facilities, utilities, equipment, systems (FUSE), and analytical instruments. Author and execute validation lifecycle documentation including: User Requirements Specification (URS) support Risk assessments IQ/OQ/PQ protocols Summary reports Support deviation investigations, contribute to structured root cause analysis, and assist in CAPA development. Perform change control impact assessments and support implementation planning. Participate on cross-functional project teams supporting capital projects and site initiatives. Represent CQV during internal and external inspections. Ensure SOPs and validation documentation meet site procedures and regulatory requirements. Utilize validation tools and qualification equipment (including data loggers such as Ellab) to support qualification activities. Contribute to maintaining facilities and equipment in a continuous state of compliance and inspection readiness. Support modernization and digitization of validation systems where possible, leveraging data-driven tools and emerging digital capabilities to enhance efficiency and compliance. Here’s What You’ll Need (Basic Qualifications): B.S. in Engineering (Chemical or Mechanical 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 the ability to support root cause investigations. Strong communication skills with the ability to collaborate across Engineering, Facilities, Operations, Automation, and Quality Assurance. 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 the 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): Ability to work 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. The key Moderna Mindsets you’ll need to succeed in the role: “We act with urgency; Action today compounds the lives saved tomorrow.” “We digitize everywhere possible using the power of code to maximize our impact on patients.” Pay & Benefits At Moderna, we believe that when you ... (truncated, view full listing at source)