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.
Lead Validation Engineer 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
Job 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
This role requires the ability to be
on-site, full-time in Devens, MA.
For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.National (US) Range
$87,780-$140,220 USD
BenefitsWhy Choose Verista?
- High growth potential and fast-paced organization with a people-focused culture
- 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
