Lab support is currently recruiting for a biotechnology client of ours in the Plantation area. Local Candidates preferred.
Scope of Function – Operation of GMP Steam Sterilization System (Autoclave). Prepare all sterilization materials to support GMP manufacturing and QC microbiology operations. Responsible for the cleaning of the GMP manufacturing suites based on GMP guidelines and internal Standard Operation Procedures (SOPs). Also; this person should support facilities department in all routine daily activities.
Reports to : Validation and Calibration Manager
1. Good GMP experience required to follow and/or execute Standard Operation Procedures (SPOs).
2. Ability to follow instructions on the operation and troubleshooting of the steam sterilization systems (autoclaves).
3. Responsible for the sterilization of all material needed to support our GMP manufacturing campaigns, as well as the sterilization of all items needed for our QC microbiology and process development labs.
4. Ensure the prompt execution of all sterilization activities based on facilities sterilization schedule, and provide timely verbal and/or written notice to end users if the schedule is compromised.
5. Work with the Facilities Department GMP Cleaning Technician to support the cleaning of the GMP manufacturing area to meet ISO and USP requirements.
6. Support the Facilities Department on the schedule and unscheduled maintenance and calibration activities.
7. Provide guidance to others departments on company’s sterilization schedule.
8. Support Facilities Department on the maintenance of the technical library and spare part systems.
9. Responsible for creating investigations reports, deviations, change controls, and submit these documentation to our Quality Assurance Department (QA) in timely manner.
10. Responsible to schedule and work with outside vendors to ensure on-time completion of all preventative maintenance and calibration activities for our steam sterilization systems and other GMP/GLP systems and equipment. All documentation should be properly documented and reviewed.
11. Maintain all sterilization and cleaning records in accordance with our company quality system and cGMP regulations.
Education, Experience and Skills Required:
Associate in Mechanical, Chemical or Electrical Engineer is preferred, and at least 5 years experience in a GMP pharmaceutical /biotech environment.
Experience on GMP guidelines and regulations. Experience on steam sterilization systems and on GMP cleaning is preferred. Experience performing preventative maintenance and calibration activities is also preferred.
Good analytical and mechanical skills. Ability to support Facilities Department in the creation of investigation reports, deviations, and change controls.