Lead Computer Systems Validation Specialist – GMP & Compliance

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

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.