Cold Chain Process Engineer
Job Description:
Our client is in need of a subject matter expert for temperature-controlled (cold chain) processes used to manufacture Medical/Pharma combo products. Qualified candidates will understand the regulatory requirements and provide expertise to establish and implement cost-effective temperature-controlled (cold chain) processes, equipment, and logistics to ensure a cGMP and GDP-compliant supply chain.
The chosen candidate will develop and implement all documentation for cold chain processes and controls including but not limited to: standard operating procedures, batch records, training documentation, pFMEAs, process/equipment validations (IQ/OQ/PQ)