6372 - CSV-Data Integrity Lead / Lead Validation Engineer

Verista; Harvard (MA); On-site; USD 87,780 - 140,220; Full time

Benefits offered by this job

Company-paid Life, Short, and Long-Term Disability Insurance

Medical, Dental & Vision insurances

401(k) Retirement Plan (Employer Matching benefit)

Paid Time Off (Rollover Option)

Tuition Reimbursement

Job summary

Verista seeks a Computer Systems Validation / Data Integrity Lead responsible for authoring and revising qualification documentation and leading data integrity strategies. This role requires a Bachelor's degree and extensive experience in GMP environments.

Located in Devens, MA, this position offers a competitive salary range of $87,780 to $140,220 and emphasizes a strong people-focused culture.

Benefits include insurance coverage, 401(k), paid time off, and tuition reimbursement.

Qualifications

• 8+ years CSV, CSA, CQV, or validation experience in GMP environments.
• Experience with computerized equipment qualification and data integrity deliverables.
• Strong technical writing and stakeholder coordination skills.

Responsibilities

• Lead CSV/DI strategy for computerized equipment qualification deliverables.
• Author/revise documentation related to DI URS, IOQ, DI OQ, UAT, etc.
• Support computerized system impact assessments.

Skills

CSV, CSA, CQV experience

Technical writing

Stakeholder coordination

Experience with ValGenesis

Knowledge of GMP processes

Education

Bachelor’s degree in Engineering or Life Sciences

Tools

GMP process/lab systems

Job description

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.

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 $87,780 USD – $140,220 USD. 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. The salary range is subject to change and may be modified in the future.

Benefits

• 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 ReimbursementTeam Social Activities
• Employee Recognition
• Employee Referral Program
• Paid Parental Leave and Bereavement

Verista is an equal opportunity employer.

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