Senior CSV Engineer: Analytical Equipment Validation

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

Benefits offered by this job

Collaborative environment

Career growth

Cutting-edge tech

Competitive compensation

401(k) matching

Ethical practices

CSV SOP ownership

Job summary

Lonza Lead Engineer - Analytical Equipment Validation is based in Portsmouth, NH, on-site, with relocation assistance for eligible candidates. The role focuses on identifying and implementing CSV best practices within GAMP and GMP frameworks and includes risk assessments, change control reviews, and protocol development.

You will own CSV SOPs, support qualification activities, and provide guidance to junior team members, serving as a Subject Matter Expert during audits and inspections.

Qualifications

• Bachelor’s Degree is required (preferably in Computer Science/Software Engineering).
• 5-10 years’ of Computer Systems Validation experience.
• Experience with 21 CFR Part 11 and ISPE GAMP guidelines as they relate to Computer Systems Validation.
• Strong written and oral communication skills.
• Strong organizational and time management skills.

Responsibilities

• Identify or create industry best practices for CSV within GAMP regulations.
• Risk assess systems and review change requests and test scripts.
• Draft protocols and initiate and review GMP documentation revisions; ownership of department procedures.
• Provide guidance to junior team members.
• Perform QMS processes (Change Control, Deviation, CAPA) and validation maintenance of computerized systems.
• Function as CSV SME in inspections and audits.

Skills

Computer Systems Validation

Risk assessment

Test script review

Documentation

Communication skills

Education

Bachelor's Degree in Computer Science/Software Engineering

Job description

Lonza Lead Engineer - Analytical Equipment Validation is based in Portsmouth, NH, on-site, with relocation assistance for eligible candidates. The role focuses on identifying and implementing CSV best practices within GAMP and GMP frameworks and includes risk assessments, change control reviews, and protocol development.

You will own CSV SOPs, support qualification activities, and provide guidance to junior team members, serving as a Subject Matter Expert during audits and inspections.