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