INCOG BioPharma is seeking a highly motivated individual with subject matter expert (SME) capabilities in sterile pharmaceutical manufacturing process controls and industrial automation for a 3rd shift Equipment Specialist role.
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 including, but not limited to: fill/finish, sanitization, component and equipment preparation.
- 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 and providing timely responses and solutions.
- SME for filling equipment and supporting systems.
- Participate and/or support process FMEAs to understand process and product risks as a pre-requisite for process validation.
- Provide technical support to manufacturing activities.
- Apply Good Engineering Practices (GEP) to drive site engineering and operational excellence.
- Work flexible hours to ensure production facility coverage.
Benefits