Process Engineer - Tech Transfer

Evonik, a contract manufacturer of pharmaceutical products, located in Birmingham AL, is currently seeking a Process Engineer to support the transfer of manufacturing processes from customers into their GMP manufacturing facility.  This position provides technical support in developing and optimizing cGMP manufacturing operations for parenteral formulations, including providing engineering support for the safe handling of highly potent active pharmaceutical ingredients.

RESPONSIBILITIES

• Support the transfer of manufacturing processes from customers into the GMP manufacturing facility
• Provide technical guidance in the understanding of root causes for out of trend or out of specification results or deviations for manufacturing processes
• Optimize production processes for both client projects and internal projects
• Train other department members on the usage of equipment, manufacturing process, documentation and tools and methodology to support the manufacturing process
• Follow cGMP regulations and procedures; generate and maintain thorough and accurate documentation in support of cGMP regulated activities
• Travel to other Evonik sites, customer sites, or equipment vendors to participate in tech transfer activities

REQUIREMENTS

• B. Sc. in a scientific or engineering field
• Minimum of 3 years in pharmaceutical tech transfer
• Good understanding of GMP regulations and documentation
• Strong written and verbal communication skills; able to clearly and effectively communicate observations, results and outcomes to management and clients
• Ability to collaborate with cross-functional teams such as analytical development, manufacturing, validation, quality assurance, quality control, and facilities on an ongoing basis