Lead Engineer - Analytical Equipment Validation
Core
Lead Computer Systems Validation (CSV) engineering to identify and implement industry best practices within GAMP regulations for computerized systems in a pharmaceutical manufacturing environment.
Role type
Lead Engineer - Computer Systems Validation
Builds
Validated computerized systems compliant with GMP and regulatory guidelines
Domain
Life Sciences / Pharmaceutical Manufacturing / Computer Systems Validation
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Computer Systems Validation (CSV), Risk assessment, Change Control, Deviation management, CAPA, GAMP principles, 21 CFR Part 11, ISPE GAMP guidelines, QMS processes, SOP development and maintenance, Audit and inspection expertise
Preferred skills
Computer Science or Software Engineering degree
Technologies
GAMP, 21 CFR Part 11, ISPE guidelines
Responsibilities
Lead collaboration between internal teams and CSV to prioritize and complete activities; 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
Seniority
Senior, hands-on IC with mentorship responsibilities