Job Description
Our client is hiring for a Senior Sterile Process Engineer in the Minneapolis area and be responsible for providing real-time process engineering support to sterile manufacturing processes. This role will support the design, procurement, and installation of GMP process equipment supporting operations & ensuring the highest Quality and Safety of all sterile products.
DUTIES:
* Provide technical support for sterile manufacturing processes in the form of data analysis, troubleshooting, problem-solving, report writing
* Develop, modify and review SOP's for operation of equipment and site processes
* Support change control implementation for the facility/manufacturing processes
* Support Tech transfer activities
* Support Clean-In-Place (CIP) and Steam-In-Place (SIP) development and validation
* Support media fill program development and validation
* Represent Technical Subject Matter Expert (SME) in teams assembled to specify, install, troubleshoot, and maintain systems, equipment, and processes
* Support day-to-day process development, production, and maintenance activities
* Participate in deviation investigations to identify root causes and define corrective and preventive actions (CAPA)
* Draft documentation such as Development Protocols and Development MBR's to support development and/or registration batches
* Work with multiple site groups to coordinate activities necessary to execute development work/engineering studies
REQUIREMENTS:
* Bachelor's degree required, preferably in Engineering, Chemistry, Microbiology, or related science
* Minimum of 7 years in a pharmaceutical technical or operations support role
* Sterile manufacturing experience required
* Technical writing - including batch documentation and investigative writing
* Knowledge of pharmaceutical GMPs and regulatory (FDA, DEA, OSHA) requirements
This is a direct hire opportunity and offers potential for relocation to MN in the form of a sign on bonus.