Description

Plan, development, implement and coordinate safety programs in pharmaceutical manufacturing process, applying engineering principles and technology from Pharmaceutical Manufacturing. Prepare Plans, templates and Reports for the Equipment Validation, Process Validation, TMV (Test Method Validation for analytical), CSV (Computer System Validation). Develop PFMEA, CFMEA, BFMEA, Risk Assessment and Risk Mitigation documents for Implants, Non-Product software, Manufacturing Process, Manufacturing Products, and equipment. Perform Gap Analysis to determine non-compliance with FDA Guidance, ISO standards. Primary worksite is Frisco TX, but relocation is possible. Req: Master degree in Pharmaceutical Manufacturing or Engineering or related with 6 months experience as Validation Engineer or Quality Engineer or related. Ref: #5609

Education

ANY GRADUATE