Verista, Inc.

Verista, Inc.

6445 - Lead CQV SME / Lead Validation Engineer

Devens, Massachusetts · Full-time

Sponsorship not specified$88k-$162kDetected 13 days ago
ComplianceGMPFDA RegulatoryCRISPRLeadershipProblem SolvingWriting

About the role

  • This role is the technical backstop for strategy, deliverable quality, risk-based qualification rationale, protocol comments, deviation handling, and execution readiness.

Responsibilities

  • 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
  • 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
  • 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
  • Able to mentor system leads, normalize document quality, resolve comments, and prevent drift across parallel system deliverables

Requirements

  • 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
  • Experience reviewing direct impact systems, computerized/automation interfaces, analytical instruments, utilities, cleanrooms, and process equipment without becoming a bottleneck
  • Deep knowledge of GMP validation lifecycle.
  • Extensive experience with ASTM E2500, ISPE, GAMP 5, FDA, and EU Annex 15.

Nice to have

  • ValGenesis experience a plus

Compensation

  • For US geography, the salary range for this position is shown below.

Benefits

  • Company-paid Life, Short-Term, and Long-Term Disability Insurance.
  • Medical, Dental & Vision insurances
  • FSA, DCARE, Commuter Benefits
  • Health Savings Account
  • 401(k) Retirement Plan (Employer Matching benefit)
  • Paid Time Off (Rollover Option) and Holidays
  • Tuition Reimbursement
  • Paid Parental Leave and Bereavement

Company info

  • 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
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This listing is sourced directly from Verista, Inc.'s careers page and normalized into a canonical job model.