Computer Systems Validation Specialist III

Lonza; Portsmouth (NH); On-site; Confidential; Full time

Benefits offered by this job

Collaborative environment

Career growth

Cutting-edge technology

401(k) match

Mentoring

Ethical practices

Job summary

Lonza in Portsmouth, NH is seeking a Computer Systems Validation Specialist III to lead assessment of new and changing computer systems for cGMP compliance, conduct risk assessments, review change requests and test scripts, and oversee CSV documentation.

The role acts as QA CSV representative on projects, provides technical guidance and mentorship to junior staff, and works on-site to drive remediation and continuous improvement.

Qualifications

• Bachelor's degree in computer science, engineering, or related field.
• At least 3+ years in computer systems validation.
• Experience in a cGMP facility.
• Familiar with 21 CFR Part 11 and ISPE GAMP guidelines.

Responsibilities

• Perform all aspects of QMS processes: Change Control, Deviations, CAPAs.
• Conduct gap assessments and initiate quality records to drive remediation.
• Author, review and approve end-to-end CSV life-cycle deliverables.
• Schedule qualification activities to meet business, manufacturing, engineering and quality goals.
• Revise and maintain SOPs for continuous improvement and compliance.
• Review engineering documents and support CSV SME activities during audits.

Skills

3+ years experience in CSV

21 CFR Part 11 compliance

Education

Bachelor's degree in computer science/engineering

Job description

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.
• Our full list of global benefits can be found here: https://www.lonza.com/careers/benefits.

What you will do:

• 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 en d to end Computer system validation life - cycle deliverables/activities.
• 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.