Lead Engineer - Analytical Equipment Validation
On-sitePortsmouth, New Hampshire, United States
Job Summary
Lead collaboration between internal teams and CSV to prioritize and complete activities on time. Risk assess systems, review change requests and test scripts, draft protocols, and initiate GMP documentation revisions. Perform QMS processes including Change Control, Deviation, and CAPA while maintaining validation documentation for computerized systems. Own and revise CSV SOPs, ensuring alignment with 21 CFR Part 11, Data Integrity, ICH Q7A, and GAMP principles. Function as a Subject Matter Expert during audits and inspections. Provide guidance to junior team members and establish industry best practices within existing regulatory frameworks.
Required Qualifications
- Bachelor's Degree
- 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
Desired Qualifications
- preferably in Computer Science/Software Engineering
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