Cold Chain Process Engineer/ Manager needed (Hybrid/ WFH Flexible)
This position is the company subject matter expert on temperature-controlled (cold chain) processes used to manufacture our products. This position 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. This position will also manage the project timeline and budget, and collaborate with internal and external teams to identify project constraints and achieve project goals.
Products include but are not limited to combination pharmaceutical/medical devices used for self-injection.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Responsibilities include, but are not limited to:
- Develop and implement cold chain processes, equipment, and logistics to minimize time of product outside of cold chain
- Provide knowledge, experience, and training to drive cold chain industry best practices throughout the organization
- Ensure cold chain quality assurance system is in place that meets all required global regulations
- 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)
For further information, please apply.