Lead CSV Engineer: Validation & GMP on-site Portsmouth

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

Benefits offered by this job

401(k) matching plan

Career growth opportunities

Competitive benefits package

Access to cutting-edge technologies

Job summary

Lonza is seeking a Lead Engineer - Analytical Equipment Validation for an on-site role in Portsmouth, NH. You will guide CSV activities, maintain alignment with 21 CFR Part 11 and GAMP, and lead audits and SOP updates.

This role requires senior CSV experience and strong regulatory knowledge, with relocation assistance available. You will collaborate across internal teams, oversee risk assessments, change requests, and validation maintenance of computerized systems, while mentoring junior staff

Qualifications

• 5–10 years of Computer Systems Validation experience.
• Experience with 21 CFR Part 11 and ISPE GAMP guidelines as they relate to CSV.
• Strong written and oral communication skills.
• Strong organizational and time management skills.

Responsibilities

• Lead collaboration between internal teams and CSV to prioritize and complete activities on time.
• Maintain knowledge of Lonza policies, 21 CFR Part 11, Data Integrity, ICH Q7A, and GAMP principles.
• Perform QMS processes (Change Control, Deviation, CAPA) and validation maintenance of computerized systems.
• Participate in audits and inspections as a Subject Matter Expert.
• Own, revise and maintain CSV SOPs.
• Support qualification activities and documentation for CSV validation in line with regulatory guidelines.

Education

Bachelor’s Degree in Computer Science/Software Engineering

Job description

Lonza is seeking a Lead Engineer - Analytical Equipment Validation for an on-site role in Portsmouth, NH. You will guide CSV activities, maintain alignment with 21 CFR Part 11 and GAMP, and lead audits and SOP updates.

This role requires senior CSV experience and strong regulatory knowledge, with relocation assistance available. You will collaborate across internal teams, oversee risk assessments, change requests, and validation maintenance of computerized systems, while mentoring junior staff