Lead CSV Engineer - Analytical Equipment Validation

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

Benefits offered by this job

Collaborative environment

Career growth

Cutting-edge tools

Competitive benefits

401(k) matching

Ethical practices

Job summary

Lonza is seeking a Lead Engineer - Analytical Equipment Validation to establish and apply best practices within the CSV framework. You will guide risk assessments, review change controls, and own GMP documentation revisions while mentoring junior staff.

This on-site role in Portsmouth involves ensuring adherence to 21 CFR Part 11, ISPE GAMP, and Data Integrity standards across computerized systems, audits, and inspections, with opportunities to advance your career in a global biotech environment.

Qualifications

• Bachelor’s Degree in Computer Science/Software Engineering.
• 5–10 years’ Computer Systems Validation experience.
• Experience with 21 CFR Part 11 and ISPE GAMP guidelines.
• Strong written and oral communication skills.
• Strong organizational and time management skills.

Responsibilities

• Lead cross-team CSV projects 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.
• Function as CSV SME in inspections and Audits.

Skills

CSV experience

Regulatory knowledge

Communication

Organization

Education

Bachelor’s degree

Job description

Lonza is seeking a Lead Engineer - Analytical Equipment Validation to establish and apply best practices within the CSV framework. You will guide risk assessments, review change controls, and own GMP documentation revisions while mentoring junior staff.

This on-site role in Portsmouth involves ensuring adherence to 21 CFR Part 11, ISPE GAMP, and Data Integrity standards across computerized systems, audits, and inspections, with opportunities to advance your career in a global biotech environment.