6444 - Lead CQV Engineer / Lead Validation Engineer

• We empower and support our colleagues
• We commit to client success at every turn
• We have the courage to do the right thing
• We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.
• We constantly acquire new skills and learn from our experiences to enhance our collective expertise

• →Own filler/isolator-related QP/DQ/QRA/data integrity/ERES/configuration/traceability inputs as applicable, plus SAT leveraging, commissioning, IOQ, QSR, blue tag, and PQ readiness where required
• →Coordinate vendor documentation and execution windows for filler/capper, isolator, labeler, inspection equipment, and associated sterile manufacturing systems
• →Support interface with cleanroom/room qualification, environmental monitoring instruments, utilities, automation/IT, operations, MS&T, and quality
• →Manage sterile equipment risks, test exceptions, deviations, punch items, and closeout evidence through final report approval
• →Lead filler/isolator C&Q scope
• →Coordinate vendor package review
• →Support VHP/sterile boundary questions if in scope
• →Author/review IOQ/QSR/TM

• Bachelor’s Degree or equivalent required
• 10+ years aseptic filling, sterile manufacturing, isolator, or barrier-system CQV experience
• Direct vial filler/capper, isolator, inspection/labeling, VHP/decontamination, glove integrity, leak testing, sterile boundary, environmental monitoring, or Annex 1-aligned experience
• Strong field execution profile: can coordinate vendor SAT, manage punch items, document discrepancies, support deviations, and drive final qualification reports
• Comfort working with quality reviewers on sterile manufacturing risks, critical parameters, acceptance criteria, and evidence expectations
• Strong technical writing and problem-solving abilities
• ValGenesis experience a plus

This role requires the ability to be on-site, full-time in Devens, MA.