Scope of Function:
Preparing and sterilizing material to support all GMP operations, as well as supporting the daily routine operations of the Facilities Department.
1) Using a GMP Steam Sterilization System (Autoclave) to sterilize all material needed to support manufacturing, micro testing, and facilities operations.
2) Assisting in the troubleshooting and repair of the steam sterilization system (Autoclave) to ensure the sterilization assurance level (SAL) on each sterilization load.
3) Performing daily verifications on facilities utilities systems, and report to the Facilities Manager any abnormality or malfunction.
4) Supporting the Facilities Department on the cleaning of all GMP manufacturing suites to keep the integrity of these ISO classified cleanrooms.
5) Responding to emergency calls generated from the company’s environmental monitoring system.
6) Supporting the Facilities Department with all GMP documentation (e.g., CAPAs, Deviations, Investigation Reports, etc.).
7) Assisting Facilities Department on all daily responsibilities.
Education and Skills required:
Education: High School diploma; Associate in Mechanical, Chemical or Electrical Engineer.
Experience: Minimum of 5 years experience in GMP Pharmaceutical/biotech environment is preferred.
Goodwin Biotech - 2 years ago
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