Lead Engineer - Analytical Equipment Validation

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.
• Function as CSV SME in inspections and Audits.

Requirements

• 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.

Qualifications

Commensurate with experience.

Skills

Not specified.

Benefits

Competitive compensation and benefits package.

401(k) matching plan.

Commitment to ethical and sustainable practices.

Access to cutting-edge technologies and tools.

Full list of global benefits can be found here: https://www.lonza.com/careers/benefits.

Pay

TBD

Schedule

TBD