Computer Systems Validation Specialist III

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

Computer Systems Validation Specialist III

United States, Portsmouth (New Hampshire)

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.

What you will get:

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.

Perform all aspects of QMS process’ – Change Control, Deviations,

CAPAs.

Perform Gap assessments to identify the gaps in processes and suggest remediation plans. Initiate the right Quality records (Deviations and CAPAs) to drive the remediation plan, as needed and execute all responsibilities as CSV project lead for projects.

Author/Review/Approve all end to end Computer system validation life-

Schedule qualification activities and personnel to meet business,

manufacturing, engineering and quality objectives.

Revise and maintain SOPs to ensure continuous improvement and

compliance to GROUP/CORP procedures.

Perform review of Engineering documents (P&IDs, SOPs, Specifications, Submittals, etc.).

Support Validation requests as a CSV SME, during Customer audits and inspections.

What we are looking for:

Bachelor’s degree in computer science, engineering, or related field.

At least 3+ years of experience in computer systems validation.

3+ years of Experience in working in a cGMP facility.

Experience with 21 CFR Part 11 and ISPE GAMP guidelines as they relate to Computer.

Systems Validation (especially for analytical computerized systems).

Works independently and in teams.

Background in biotech, pharma, or medical device industry.

Ability to work independently and on-site in Portsmouth NH.

About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.