Engineer II, Validation

Role Overview

In this role, you will perform the duties according to the Moderna Commissioning, Qualification and Validation (CQV) program and execute assigned qualification activities. This role will own the delivery of the capital projects, site re‑qualification and periodic review programs, ensuring systems and equipment remain in an operational state of compliance.

• Perform commissioning, qualification, and validation activities for Moderna’s GMP manufacturing facility which includes raw material, Drug Substance, Formulation, Drug Product, Finished Goods, and personalized medicine capabilities.
• Work with external validation service providers and ensure commitment to key stakeholders is met.
• Ensure the validated status of site facilities, utilities, equipment, and processes is established and maintained in accordance with internal procedures, regulatory requirements, and industry guidance / standards.
• Support new equipment qualification activities for capital and operational projects.
• Assist in investigation and reviews of deviation investigations related to manufacturing process equipment, utilities, automation, computer systems, validation, and laboratory instruments.
• Provide support for equipment and systems in use at Moderna facilities (Controlled Temperature Units [Refrigerators, Freezer, Incubators], Analytical Instruments [used for in‑process and quality control testing], Manufacturing Unit Operations [Ultrafiltration, Chromatography, Mixers, Tanks / Vessels, Bioreactors / Fermenters], etc.).
• Support internal and external audits/inspections as part of the Commissioning, Qualification and Validation program.
• Participate in continuous quality system improvements and support implementing improvements in the GMP Validation and Change Control Programs.
• Drive results by owning and completing validation initiatives / projects against identified timelines.
• Own quality records such as Change Controls, Deviations, Corrective / Preventative Actions (CAPAs), and continuous improvement initiatives related to validation activities.
• Additional duties as may be assigned from time to time.

• B.S. in Life Science or Engineering Degree (Mechanical, Computer Science or Biomedical Engineering, etc.). A Master’s degree in the above discipline is preferred.
• Minimum of 2+ years in commissioning, qualification, validation, or quality experience in cGMP manufacturing environments.

• Strong understanding of validation principles including but not limited to facilities, utilities, equipment, and systems (FUSE).
• Excellent technical documentation generation and review skills ensuring the content is technically sound, adheres to applicable site procedures, and is suitable for regulatory submission / inspection.
• Ability to use a structured problem‑solving approach to investigate issues, determine true root cause, and develop effective corrective and preventative actions.
• Excellent interpersonal and communication skills (verbal and written) are required; expected to present work to peers and cross‑functional managers and influence leadership decisions; technical writing skills required.
• Ability to interact well with other groups and take ownership of and follow through on assignments; must drive results on multiple complex assignments simultaneously with minimal direction.
• Ability to represent Moderna’s interests, objectives, and policies in a professional and responsible manner.
• A desire to make an impact as part of a high‑growth, transformational company that is Bold, Relentless, Curious, and Collaborative.

For this role, we are currently unable to offer immigration sponsorship. Candidates must already hold work authorization in the U.S. and be able to maintain that status without the need for future sponsorship.

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,…