Equipment Specialist Summary: INCOG BioPharma is seeking a highly motivated individual with subject matter expert (SME) capabilities in sterile pharmaceutical manufacturing process controls and industrial automation. The Equipment Specialist is a key technical role within INCOG BioPharma Operations.
Requirements
- Follow production and manufacturing procedures
- Perform duties in Grade C, D, and controlled non-classified cleanrooms
- Perform aseptic manipulations within Grade A isolators
- Safely operate production equipment including setup and changeovers
- Lead batch start up activities and execution of production cycles
- Accurately document data and complete batch records
- Execute validation/engineering protocols as needed
- Train others in various manufacturing tasks
- Maintain production equipment and troubleshoot issues
- Support equipment optimization efforts and continuous improvement efforts
- Resolve issues that arise in day-to-day running of operation
- Apply Good Engineering Practices (GEP) to drive site engineering and operational excellence
- Work flexible hours to ensure production facility coverage