Senior CSV Lead: Computer Validation in Pharma

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

Benefits offered by this job

Collaborative work environment

Career growth opportunities

Cutting-edge technologies and tools

Competitive compensation and benefits

Job summary

Lonza in Portsmouth, NH, is seeking a Computer Systems Validation Specialist III. The role leads teams to assess new and changing computer systems for compliance, conducts risk assessments, reviews change requests and test scripts, drafts protocols, and oversees GMP documentation revisions.

The CSV Specialist III acts as the QA CSV representative for projects, provides technical guidance, and mentors junior colleagues while supporting on-site validation activities.

Qualifications

• Bachelor's degree in computer science, engineering, or related field.
• At least 3+ years of experience in computer systems validation.
• 3+ years in a cGMP facility.
• Experience with 21 CFR Part 11 and ISPE GAMP guidelines as they relate to Computer Systems Validation.
• Systems Validation for analytical computerized systems.
• Ability to work independently and on-site in Portsmouth, NH.

Responsibilities

• Perform all aspects of QMS processes: Change Control, Deviations, CAPAs.
• Conduct gap assessments and initiate quality records to drive remediation.
• Author/Review/Approve end-to-end CSV lifecycle deliverables.
• Schedule qualification activities to meet objectives across manufacturing, engineering and quality.
• Revise SOPs for continuous improvement and compliance with GROUP/CORP procedures.
• Review Engineering documents (P&IDs, SOPs, specifications, submittals).
• Support validation requests as a CSV SME during audits and inspections.

Skills

Independent work

Team collaboration

Biotech/pharma/medical device

On-site Portsmouth NH

Education

Bachelor's degree in CS/engineering or related field

Job description

Lonza in Portsmouth, NH, is seeking a Computer Systems Validation Specialist III. The role leads teams to assess new and changing computer systems for compliance, conducts risk assessments, reviews change requests and test scripts, drafts protocols, and oversees GMP documentation revisions.

The CSV Specialist III acts as the QA CSV representative for projects, provides technical guidance, and mentors junior colleagues while supporting on-site validation activities.