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. You will support commissioning, qualification, and validation (CQV) activities to keep facilities, utilities, equipment, systems (FUSE), and analytical instruments 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 in a highly technical, site-based role embedded within our manufacturing ecosystem. 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. It is not eligible for remote work. Applicants must hold current U.S. work authorization; no immigration sponsorship will be offered. 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. Pay & Benefits The salary range for this role is $74,000.00 – $118,400.00. Salary decisions are based on competencies, education, experience, and business needs. The successful candidate may be eligible for an annual discretionary bonus, incentive compensation, or equity award, subject to eligibility criteria and performance. Best‑in‑class healthcare coverage and voluntary benefit programs. Holistic well‑being support, including fitness, mindfulness, and mental health resources. 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. Location‑specific perks and extras. Equal Opportunities Moderna is committed to equal employment opportunity and non‑discrimination for all employees and qualified applicants, regardless of race, color, sex, gender identity or expression, age, religion, national origin, ancestry, citizenship, ethnicity, disability, military or veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Qualified applicants are invited to apply. Export Control Notice This position may involve access to technology or data subject to U.S. export control laws. Employment is contingent upon the applicant’s ability to handle export‑controlled information in compliance with U.S. law. Only U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. Non‑U.S. persons may not apply for an export control license. #J-18808-Ljbffr Initial Therapeutics, Inc.