6445 - Lead CQV SME / 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

• →Provide senior technical governance for commissioning, qualification, and validation activities across facilities, utilities, process equipment, analytical instruments, automation systems, and cleanroom qualifications. Ensure qualification strategies align with regulatory expectations, industry best practices, project objectives, and quality requirements
• →Mentor and provide technical oversight to system leads and CQV engineers, offering guidance on qualification execution, risk-based decision making, protocol development, technical problem solving, and regulatory compliance while promoting consistency across multiple workstreams
• →Review and approve system qualification strategies including Commissioning Plans, Qualification Plans, Validation Master Plans (VMPs), and lifecycle deliverables to ensure appropriate application of risk-based commissioning and qualification methodologies in accordance with ASTM E2500, ISPE Baseline Guides, and GAMP 5 principles
• →Provide technical leadership in resolving complex protocol execution, deviation, and investigation issues, evaluating technical impact, determining appropriate corrective actions, and ensuring timely closure of deviations while maintaining project schedules and compliance with cGMP requirements
• →Support vendor leveraging and risk-based qualification approaches by evaluating vendor documentation, Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), and commissioning packages for qualification suitability. Develop and review Quality Risk Assessments (QRA), Design Qualifications (DQ), Installation/Operational Qualification (IOQ) strategies, Qualification Summary Reports (QSR), and Traceability Matrices (TM) to optimize testing while ensuring complete regulatory compliance
• →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

• Bachelor’s Degree or equivalent required
• 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
• 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

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