Job Overview: We are seeking a Lead Validation Engineer to lead C&Q scope for drug product filling, isolator, and related aseptic manufacturing equipment. This is a specialist role for someone who has qualified vial filling/capping and isolator systems and can manage sterile boundary risk, vendor package questions, SAT/IOQ execution issues, and quality-facing closeout.
Lead Validation Engineer Responsibilities:
- 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
Job Requirements:
- 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.