Validation Engineer
Core
Ensures compliance and performance of plant systems through equipment/system/process validation, requalification, and testing in a cGMP regulated environment.
Role type
Validation Engineer (cGMP)
Builds
Validated equipment, systems, and processes for pharmaceutical manufacturing
Domain
Pharmaceutical manufacturing / cGMP compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP knowledge, aseptic techniques, HEPA filter testing, airflow pattern testing, statistical analysis, report writing, deviation management, root-cause analysis, risk assessment, change control
Preferred skills
IQ/OQ/PQ protocol generation, analytical datalogger programming, cleaning validation, process validation, computer system validation
Technologies
temperature/humidity dataloggers, smoke generators, photometers, velocity meters, lyophilizers, sterilizers, incubators
Responsibilities
Schedule and execute equipment requalifications and validation studies; program and operate analytical instruments for chamber qualifications; develop and improve validation programs; perform HEPA filter and critical area testing; represent Technical Services in system specification and troubleshooting teams
Seniority
Entry-level to Mid-level, hands-on IC
