Job Description: The Lead Validation Engineer leads GMP equipment installation, commissioning, and qualification projects supporting large-molecule biologics manufacturing. This role supports upstream and downstream processes and ensures projects are executed safely, on schedule, and in compliance with regulatory and quality requirements.
Responsibilities: - Lead end-to-end CQV execution for GMP equipment projects, managing activities from installation through IQ, OQ, and PQ for biologics manufacturing systems including bioreactors, media/buffer preparation, chromatography, filtration, and associated utilities.
- Drive project planning and execution, developing and maintaining integrated schedules, budgets, and resource plans while proactively identifying risks and implementing mitigation strategies to support on-time, compliant delivery.
- Coordinate and direct cross-functional teams (Engineering, Manufacturing, MSAT, Quality, Validation, Automation, and vendors) to ensure alignment on technical requirements, execution strategy, and readiness for qualification milestones.
- Ensure full regulatory and quality compliance, including adherence to cGMP, biosafety requirements, and site quality systems; review and approve URSs, FAT/SAT documentation, installation packages, and qualification protocols.
- Serve as the primary technical and communication lead for equipment CQV activities, providing regular status updates to stakeholders and supporting change controls, deviations, and CAPAs related to equipment implementation and qualification.
- Lead CQV activities for facility and utility upgrade projects, including AHU replacements, boiler replacements, generator improvements, clean steam generator replacements, RODI (reverse osmosis deionized) water skid upgrades, parts washer upgrades, and installation and qualification of autoclaves.
Requirements: - Bachelor's degree in Engineering, Life Sciences, or a related technical field; advanced degree or relevant certifications (e.g., CQV, PMP) preferred
- 7+ years of progressive experience in Commissioning, Qualification, and Validation (CQV) within GMP-regulated pharmaceutical or biotechnology manufacturing environments
- Demonstrated experience leading GMP equipment and utility projects from installation through IQ, OQ, and PQ, supporting biologics manufacturing processes such as CHO cell culture, media/buffer preparation, chromatography, filtration, and clean utilities
- Strong working knowledge of cGMP regulations, biosafety requirements, and site quality systems, with experience supporting regulatory inspections and audit readiness
- Proven ability to lead cross-functional teams and vendor partners, manage project schedules and budgets, and communicate technical status, risks, and mitigation plans to stakeholders
- Hands-on experience reviewing and approving URSs, FAT/SAT documentation, installation packages, qualification protocols, and supporting change controls, deviations, and CAPAs
- Preferred experience supporting facility and utility upgrade projects, including AHU replacements, boiler replacements, generator improvements, clean steam generator replacements, RODI water skid upgrades, parts washer upgrades, and installation/qualification of autoclaves
