Lead and execute qualification and computer system validation (CSV) activities for Quality Control (QC) laboratories, driving lifecycle management of analytical instruments and non-analytical utilities
Job Summary
Lead and execute qualification and computer system validation (CSV) activities for Quality Control (QC) laboratories, driving lifecycle management of analytical instruments and non-analytical utilities.
Author and review lifecycle documentation, oversee vendor qualifications, and perform installation, configuration, and testing for systems with and without software.
Guide and supervise cross-functional project teams, train and mentor colleagues on CSV, Annex 11/Part 11, data integrity, and qualification best practices.
Matching Summary
Lead and execute qualification and computer system validation (CSV) activities for Quality Control (QC) laboratories, driving lifecycle management of analytical instruments and non-analytical utilities.
Skills & Requirements
Must-have
equipment qualification IQ/OQ/PQ
Computer System Validation (CSV)
data integrity controls
GAMP 5
21 CFR Part 11
EU GMP Annex 11
Nice-to-have
cross-functional coordination
project planning
problem-solving skills
lab automation integration
Key Requirements
MSc or PhD in Natural Sciences, Engineering, Computer Science, or related field
Bachelor’s degree with substantial, relevant GMP experience
Proven experience qualifying laboratory equipment in a GMP environment
Hands-on CSV experience for laboratory/software systems
Strong documentation skills across the validation lifecycle
Practical understanding of data integrity controls