6372 - CSV-Data Integrity Lead / Lead Validation Engineer
About The Position
Verista's 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities. Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day. Company Culture Guidelines & Values: 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 Job Overview: We are seeking a Computer Systems Validation / Data Integrity Lead to support qualification deliverables for equipment with computerized system and data integrity components. The primary focus will be CSV and related DI deliverables, including DI URS, commissioning protocol support, IOQ, individual and grouped DI OQ, UAT, DIRA, PQ, and QSR documentation.
Requirements
- Bachelor's degree in Engineering, Life Sciences, or a related technical discipline
- 8+ years CSV, CSA, CQV, or validation experience in GMP environments
- Experience with computerized equipment qualification and data integrity deliverables
- Experience authoring/executing IQ/OQ/PQ, UAT, DI assessments, DIRA, and QSRs
- Strong technical writing and stakeholder coordination skills
- Experience with GMP process/lab systems
- Experience in biologics manufacturing
- Experience with ValGenesis
Responsibilities
- Lead CSV/DI strategy for computerized equipment qualification deliverables
- Author/revise DI URS, IOQ, DI OQ, UAT, DIRA, PQ, and QSR documentation
- Support computerized system impact assessments and data integrity risk considerations
- Partner with equipment SMEs, CQV lead, quality, automation/IT, and vendor teams
- Support execution, discrepancy resolution, and package closeout
- Ensure documentation aligns with GMP, data integrity, and site validation expectations
- Support Phase 1 and Phase 2 CSV/DI deliverables as required
Benefits
- Competitive pay plus performance-based incentive programs
- Company-paid Life, Short-Term, and Long-Term Disability Insurance.
- Medical, Dental & Vision insurances
- FSA, DCARE, Commuter Benefits
- Supplemental Life, Hospital, Critical Illness and Legal Insurance
- Health Savings Account
- 401(k) Retirement Plan (Employer Matching benefit)
- Paid Time Off (Rollover Option) and Holidays
- As Needed Sick Time
- Tuition Reimbursement
- Team Social Activities (We have fun!)
- Employee Recognition
- Employee Referral Program
- Paid Parental Leave and Bereavement
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What This Job Offers
Job Type
Full-time
Career Level
Senior
