Manufacturing Engineer

Major Duties and Responsibilities:
Provide Engineering support of automated manufacturing production equipment for both upstream and downstream processes. Included but not limited to bioreactors, depth filtration, centrifugation, column chromatography, and Ultrafiltration/diafiltration systems. Responsibilities include assisting with troubleshooting Clean in Place (CIP), Steam in Place (SIP), and process operations for a particular process step.
Provide support to Manufacturing, Quality, Automation, and Validation for deviation investigation, change controls, and CAPA's through participation in cross functional team environment.
Support Maintenance activities, including review of Preventative Maintenance (PM), drawing updates, and support of out of Specification investigations related to Calibration of critical equipment.
Support future capital projects from start to finish, including defining user requirements, supporting installation, commissioning, and Validation activities including IQ, OQ, PQ, ensuring equipment functions to current User requirement specifications. Ensure construction activities are performed to site specifications; PM programs are updated as needed, and perform design review (including Factory and Site acceptance testing as needed). Develops user requirements for new equipment including supporting installation with the collaboration of user departments.
Knowledge / Skill:
Knowledge of manufacturing engineering and science generally attained through studies resulting in a B.S., in engineering (Chemical or Mechanical preferred), a related discipline, or its equivalent.
A minimum of 3 to 4 years relevant experience (or equivalent) in biopharmaceutical industry or its equivalent including experience with manufacturing equipment support in the Biotechnology manufacturing industry.
The individual should have the ability to execute multiple complex technical projects and have some familiarity with the manufacturing operations of large scale production facilities as well as GMP experience.
Knowledge of engineering principles related to typical biopharmaceutical upstream and downstream processing and support equipment including but not limited to bioreactors, filtration and ultra filtration, CIP, SIP, centrifugation, chromatography, autoclaves, and glass washers.
Knowledge of Delta V, or other process automation software desirable; ability to use process historian and analyze data to assist troubleshooting.
Demonstrated effectiveness in both a team environment and an individual contributor role.
Ability to work extended hours or a modified work schedule as required for coverage of 24/7 manufacturing operation. The position is Monday through Friday, first shift, but requires on-call availability.

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