Verista, Inc.
6444 - Lead CQV Engineer / Lead Validation Engineer
Devens, Massachusetts · Full-time
Sponsorship not specified$88k-$147kDetected 13 days ago
Problem SolvingWriting
About the role
- We are seeking a Lead Validation Engineer to lead C&Q scope for drug product filling, isolator, and related aseptic manufacturing equipment.
Responsibilities
- 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
- Support VHP/sterile boundary questions if in scope
- 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.
Requirements
- Bachelor's Degree or equivalent required
- 10+ years aseptic filling, sterile manufacturing, isolator, or barrier-system CQV experience
- Comfort working with quality reviewers on sterile manufacturing risks, critical parameters, acceptance criteria, and evidence expectations
Nice to have
- 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
- ValGenesis experience a plus
- Competitive pay plus performance-based incentive programs
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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