Verista, Inc.
6442 - Senior CQV Engineer / Senior Validation Engineer
Devens, Massachusetts · Senior · Full-time
Sponsorship not specified$70k-$114kDetected 13 days ago
CRISPR
About the role
- We are seeking a Senior CQV Engineer to lead C&Q documentation, vendor leveraging, walkdowns, commissioning readiness, and qualification execution for viral vector drug substance process equipment and related single-use process systems.
Responsibilities
- Own process equipment document set and execution readiness
- Lead system walkdowns
- Manage discrepancies and punch/deviation handoff
- Own assigned process equipment document sets from planning through execution and
- Manage turnover package review, receipt verification, construction/commissioning evidence, punch items, test exceptions, and deviation handoff
- Feed accurate system status, blockers, and recovery needs into PM/document control trackers
- Own assigned process equipment document sets from planning through execution and QSR: QP/DQ/QRA/DI/ERES/configuration/traceability as applicable, commissioning documents, IOQ/PQ, blue tag, and closeout
- This role needs a field-capable biologics process equipment validation lead who can own systems through turnover, SAT, commissioning, IOQ, evidence review, discrepancy resolution, and final reports.
Requirements
- Bachelor's Degree or equivalent required
- 10+ years process equipment CQV in biologics, cell therapy, gene therapy, viral vector, vaccine, or sterile manufacturing environments
- Experience reviewing vendor FAT/SAT packages and turning them into leveraged qualification evidence with clear punch-item and deviation handling
- Experience with Bioreactors, Chromatography systems, TFF systems, Centrifuges, Mixing systems, Single-use technologies
Nice to have
- ValGenesis execution/routing experience is preferred
- candidate must be comfortable with electronic protocol evidence expectations.
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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