Computer Systems Validation Specialist III

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

Benefits offered by this job

401(k) matching

Competitive compensation

Career growth

Mentoring

Job summary

Lonza Portsmouth, NH is seeking a Computer Systems Validation Specialist III to lead teams in assessing new and changing computer systems for compliance with company policies and industry guidance. You will 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 projects, providing technical guidance and mentoring to junior team members while ensuring on-site execution and

Qualifications

• Bachelor’s degree in computer science, engineering, or related field.
• 3+ years of experience in computer systems validation.
• 3+ years of experience in a cGMP facility.

Responsibilities

• Perform all aspects of QMS processes – Change Control, Deviations, CAPAs.
• Perform Gap assessments to identify gaps in processes and suggest remediation plans.
• Initiate appropriate Quality records (Deviations and CAPAs) to drive remediation and lead CSV projects.
• Author/Review/Approve end-to-end CSV lifecycle deliverables and activities.
• Schedule qualification activities and personnel to meet objectives.
• Revise and maintain SOPs for continuous improvement and compliance with procedures.
• Review Engineering documents (P&IDs, SOPs, Specifications, Submittals).
• Support Validation requests as a CSV SME during audits and inspections.

Skills

CSV experience

QMS processes

Lead / mentorship

Independent work

Risk assessment

Education

Bachelor’s degree in CS/Engineering or related

Tools

21 CFR Part 11

ISPE GAMP guidelines

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 end 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. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.