Validation Specialist ( 18 Months Agency Contract )
Core
Execute and close out validation projects for production areas including Process, Cleaning, Software, Utility, and Facility to ensure compliance in a cGMP environment.
Role type
Validation Specialist (cGMP)
Builds
Validated production processes and facilities for pharmaceutical manufacturing
Domain
Healthcare / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP compliance knowledge, technical writing, risk assessment (FMEA), validation project management, functional testing execution, deviation tracking
Preferred skills
Experience in oral solid dose facilities, knowledge of Annex 11 and Annex 15
Technologies
FAT, IQ, OQ, PQ, FMEA, PVP
Responsibilities
Generate, execute, and close out validation projects; Write, execute, and report validation activities; Participate in project teams to determine schedules and validation levels; Perform validation functional testing; Track and resolve deviations during qualification activities
Seniority
Mid-level, hands-on IC
