Senior CSV Specialist — Lead GMP Systems Validation

Lonza Group; Portsmouth (NH); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

401(k) matching

Competitive compensation

Career growth

Access to cutting-edge tools

Job summary

Lonza in Portsmouth, NH seeks a Computer Systems Validation Specialist III to lead validation efforts for computer systems. You’ll assess risks, draft protocols, review change controls, and mentor junior staff while representing QA CSV on project teams.

Ideal candidates have a strong background in cGMP environments and familiarity with Part 11 and GAMP guidelines to ensure compliant system life cycles.

Qualifications

• Bachelor’s degree in computer science, engineering, or related field.
• Minimum 3+ years in computer systems validation.
• 3+ years in a cGMP facility environment.
• Experience with 21 CFR Part 11 and ISPE GAMP guidelines.
• Experience validating analytical computerized systems.
• Ability to work independently and in teams.
• Background in biotech, pharma, or medical devices.

Responsibilities

• Lead teams assessing new/changed computer systems for compliance.
• Conduct risk assessments, review change requests, draft protocols.
• Oversee GMP documentation revisions and QA CSV representation.
• Provide technical guidance and mentorship to juniors.
• Schedule qualification activities to meet objectives.
• Revise SOPs for continuous improvement and compliance.
• Support validation requests during audits and inspections.

Skills

Computer Systems Validation

Risk assessment

Mentorship

Independent worker

Education

Bachelor’s degree in computer science or engineering

Tools

21 CFR Part 11

ISPE GAMP guidelines

Job description

Lonza in Portsmouth, NH seeks a Computer Systems Validation Specialist III to lead validation efforts for computer systems. You’ll assess risks, draft protocols, review change controls, and mentor junior staff while representing QA CSV on project teams.

Ideal candidates have a strong background in cGMP environments and familiarity with Part 11 and GAMP guidelines to ensure compliant system life cycles.