Senior CQV Lead: Validation Strategy & Execution

Veristainc; Harvard (MA); On-site; USD 87,880 - 161,654; Full time

Benefits offered by this job

Competitive pay

401(k) Retirement Plan (Employer Match

Paid Time Off and Holidays

Tuition Reimbursement

Healthcare benefits

Job summary

Verista is seeking a Lead Validation Engineer to provide senior technical governance across the CQV lifecycle for facilities, utilities, process equipment, analytical instruments, automation, and room qualifications. This role is the technical backstop for strategy, deliverable quality, risk-based qualification rationale, protocol comments, deviation handling, and execution readiness.

This role requires on-site, full-time work in Devens, MA, with responsibilities including reviewing

Qualifications

• 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

Responsibilities

• Provide senior technical governance for commissioning, qualification, and validation activities across facilities, utilities, process equipment, analytical instruments, automation systems, and cleanroom qualifications.
• 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, FAT, SAT, and commissioning packages for qualification suitability. Develop and review QRA, DQ, IOQ strategies, QSR, and 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.

Skills

Risk-based qualification judgment

Technical writing

Problem-solving abilities

Mentoring system leads

Education

Bachelor’s Degree or equivalent

Tools

ValGenesis

Job description

Verista is seeking a Lead Validation Engineer to provide senior technical governance across the CQV lifecycle for facilities, utilities, process equipment, analytical instruments, automation, and room qualifications. This role is the technical backstop for strategy, deliverable quality, risk-based qualification rationale, protocol comments, deviation handling, and execution readiness.

This role requires on-site, full-time work in Devens, MA, with responsibilities including reviewing