Computer Systems Validation Specialist
Salary: $56,000 - 73,500 per year
Requirements:
Bachelors degree in computer science, engineering, or a related discipline. 3+ years of experience in computer systems validation. 3+ years of experience working in a cGMP environment. Knowledge of 21 CFR Part 11 and ISPE GAMP guidelines as they apply to computerized systems validation. Experience in biotech, pharma, or medical device environments. Ability to work both independently and collaboratively. Willingness to work on-site in Portsmouth, NH.
Responsibilities:
Lead assessments of new and changing computer systems to help ensure alignment with company standards and industry expectations. Carry out risk evaluations, review change requests and test scripts, and prepare validation protocols. Oversee revisions to GMP documentation and support quality records such as deviations and CAPAs. Perform gap analyses, recommend remediation actions, and initiate the appropriate quality records to support corrective plans. Author, review, and approve end-to-end computer system validation deliverables and activities. Schedule qualification activities and coordinate personnel to meet business, manufacturing, engineering, and quality goals. Maintain and improve SOPs to support ongoing compliance with group and corporate procedures. Review engineering documents including P&IDs, SOPs, specifications, and submittals. Support validation activities as a subject matter expert during customer audits and inspections. Serve as the QA CSV representative on small and large projects while guiding and mentoring junior team members.
Technologies:
Support
More:
We are a globally connected life sciences company with more than 30 sites across five continents, working together to manufacture the medicines of tomorrow. Our culture is built on collaboration, accountability, excellence, passion, and integrity, and we value ideas that can improve millions of lives. We offer a collaborative and inclusive environment, strong leadership and mentoring, career growth opportunities, access to advanced technologies and tools, competitive compensation and benefits, and 401(k) matching. This role is based in Portsmouth, NH, and relocation assistance may be available for eligible candidates and their families.
last updated 28 week of 2026
