6372 - CSV-Data Integrity Lead / Lead Validation Engineer

United States·Devenslead

QA & TestingValidation Engineer

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Quick Summary

Key Responsibilities

Lead CSV/DI strategy for computerized equipment qualification deliverables Author/revise DI URS, IOQ, DI OQ, UAT, DIRA, PQ,

Requirements Summary

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 impa

Technical Tools

QA & TestingValidation Engineer

Description

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

Responsibilities

~1 min read

→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

Requirements

~2 min read

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.

*Verista is an equal opportunity employer.

National (US) Range

$87,780—$140,220 USD

Benefits

Why 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

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For more information about our company, please visit us at Verista.com