Computer Systems Validation Specialist III

Computer Systems Validation Specialist III

Location:

Portsmouth, NH. Relocation assistance is available for eligible candidates and their families, if needed.

The Computer Systems Validation (CSV) Specialist III leads teams in assessing new and changing computer systems to ensure compliance with company policies and industry guidance. They conduct risk assessments, review change requests and test scripts, draft protocols, and oversee GMP documentation revisions. This role acts as the QA CSV representative for small and large-scale projects while providing technical guidance and mentorship to junior team members.

• A collaborative and inclusive work environment.
• Opportunities for career growth and development.
• Access to cutting‑edge technologies and tools.
• Competitive compensation and benefits package.
• 401(k) matching plan.
• Supportive leadership and mentoring.
• Commitment to ethical and sustainable practices.

Full benefits list available at

• Perform all aspects of QMS processes, including Change Control, Deviations, and CAPAs.
• Conduct gap assessments to identify process gaps and propose remediation plans; initiate appropriate records (Deviations and CAPAs) as needed and act as CSV project lead.
• Author, review, and approve end‑to‑end computer system validation lifecycle deliverables and activities.
• Schedule qualification activities and allocate personnel to meet business, manufacturing, engineering, and quality objectives.
• Revise and maintain SOPs to ensure continuous improvement and compliance with corporate procedures.
• Review engineering documents (P&IDs, SOPs, specifications, submittals, etc.).
• Support validation requests as a CSV SME during customer audits and inspections.

• Bachelor’s degree in computer science, engineering, or a related field.
• At least 3 years of experience in computer systems validation.
• At least 3 years of experience working in a cGMP facility.
• Experience with 21 CFR Part 11 and ISPE GAMP guidelines as they relate to computer systems.
• Experience in systems validation, especially for analytical computerized systems.
• Ability to work independently and in teams.
• Background in biotech, pharma, or medical device industry.
• Ability to work independently and on‑site in Portsmouth, NH.

At Lonza, our people are our greatest strength. With 30+ sites across five continents, we manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion, and Integrity guide how we work together.

Reference: R76317