Senior Sterile Process Support Engineer



Advert ID



New Hope

Job Type




Salary Range

USD93828-150000 per year

No. of Openings


Branch Information

Minnesota Engineering - (USA) 3600 Minnesota Drive Suite 850 MN Edina , MN 55435



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.


* 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


* 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.