Senior CQV Delivery Lead / Validation SME

Job Title – Senior CQV Delivery Lead / Validation SME

Job Location Devens MA  -Onsite from day one -4x days on site / 1 remote (May go to 3 days once onboarded) -Need to be local OR WHO CAN RELOCATE FROM DAY ONE

End Client – BMS

Duration - 6 Months

Visa  - Any Visa except H1B,CPT

Mode Of Interview -  Phone/Skype

Note – Need LinkedIn and we have to submit before end of the day.

Provide senior technical governance across the C&Q lifecycle for a mixed portfolio of facility, utility, process equipment, analytical instrument, automation, and room qualification scope. This role is the technical backstop for strategy, deliverable quality, risk-based qualification rationale, protocol comments, deviation handling, and execution readiness.

Project scope to screen against:

• Must be able to support a viral vector / gene therapy manufacturing environment with aseptic filling interfaces and single-use process equipment.
• Document status varies by class: some requirements and impact assessments exist in draft/review/approval state and must be confirmed, finalized, or used to create downstream lifecycle documents.
• Lifecycle document set includes QP, QRA, data integrity risk assessment, ERES assessment, configuration specification, traceability matrix, commissioning protocol/report, IOQ, PQ where applicable, and QSR.
• Execution scope includes vendor-package leveraging, turnover package review, receipt verification, commissioning, IOQ, PQ, configuration verification, loop check where applicable, and requalification decisions.

Required experience:

• 15 years CQV/validation
• Direct impact system lifecycle
• Biologics, aseptic filling, isolators, utilities/process systems
• Senior reviewer/approver quality mindset.
• Deep knowledge of GMP validation lifecycle.
• Extensive experience with ASTM E2500, ISPE, GAMP 5, FDA, and EU Annex 15.
• Strong technical writing and problem-solving abilities
• ValGenesis experience a plus

Technical screening criteria:

• Hands-on validation leader with 15 years in GMP CQV, ideally across biologics, viral vector, cell therapy, gene therapy, aseptic manufacturing, or complex sterile facilities.
• Strong risk-based qualification judgment: can decide when to leverage vendor FAT/SAT packages, when to write project-specific testing, and how to defend the rationale to quality stakeholders.
• Experience reviewing direct impact systems, computerized/automation interfaces, analytical instruments, utilities, cleanrooms, and process equipment without becoming a bottleneck.
• Able to mentor system leads, normalize document quality, resolve comments, and prevent drift across parallel system deliverables.

Responsibilities:

• Provide senior technical governance
• mentor system leads
• review qualification strategy
• resolve protocol/deviation issues
• support vendor leveraging, QRA/DQ/IOQ/QSR/TM strategy.

Project deliverables / ownership:

• Review and guide QP, QRA, data integrity risk assessment, ERES assessment, configuration specification, traceability matrix, commissioning protocol/report, IOQ/PQ, blue tag, and QSR strategy.
• Own technical escalation for protocol exceptions, discrepancies, punch items, deviations, and test evidence gaps.
• Support family/grouping rationale where systems can be qualified efficiently while maintaining traceability and defensibility.
• Partner with PM and document manager to keep 5-business-day review and approval cycles realistic and clean.

Tools, field work, and interfaces:

• ValGenesis familiarity is important for electronic C&Q lifecycle execution and routing.
• Must communicate clearly with quality, engineering, operations, MS&T, IT/digital plant, vendors, and field execution resources.
• Onsite presence is expected during critical reviews, walkdowns, and execution windows in Devens, MA.

Sourcing profile: Search for Senior Validation SME, CQV Delivery Lead, CQV Technical Lead, Validation Lead, Biologics CQV SME, Aseptic CQV Lead, Viral Vector Validation SME.