Senior CSV Engineer: Analytical Systems Validation

Lonza Group Ltd.; Portsmouth (NH); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Collaborative environment

Career growth opportunities

Cutting-edge technologies and tools

Competitive compensation

401(k) matching plan

Ethical and sustainable practices

Job summary

Lonza Group Ltd. is seeking a Lead Engineer - Analytical Equipment Validation to drive computer systems validation within GMP frameworks at our Portsmouth, NH site.

You will lead cross-functional CSV activities, assess risks, and oversee change controls and data integrity in accordance with 21 CFR Part 11 and ISPE GAMP guidance. The role requires a Bachelor’s degree in a computer science/engineering field and 5–10 years of CSV experience, with strong communication skills and a track record of

Qualifications

• Bachelor’s degree in a related field.
• 5–10 years of Computer Systems Validation experience.
• Experience with 21 CFR Part 11 and ISPE GAMP guidelines.
• Strong written and oral communication 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.

Skills

CSV leadership

Regulatory knowledge

Risk assessment

Written communication

Education

Bachelor’s Degree in Computer Science/Software Engineering

Job description

Lonza Group Ltd. is seeking a Lead Engineer - Analytical Equipment Validation to drive computer systems validation within GMP frameworks at our Portsmouth, NH site.

You will lead cross-functional CSV activities, assess risks, and oversee change controls and data integrity in accordance with 21 CFR Part 11 and ISPE GAMP guidance. The role requires a Bachelor’s degree in a computer science/engineering field and 5–10 years of CSV experience, with strong communication skills and a track record of