1. Bachelor in Engineering or pharmaceutical production.
2. Minimum of 5 years of experience in facility operation and management within pharmaceutical or medical device industries. Or at least 8 years of industry experience in calibration in pharmaceutical, medical device, healthcare, or food industries.
3. Detailed knowledge of the operation of pharmaceutical utility systems (e.g. PW, WFI, Pure Steam, Compressed Air, and HVAC) and general building services (access control, boiler, waste neutralization, chillers, cooling towers, electrical power, emergency generators, compressed gases)’
4. Technical knowledge regarding the design, operation, preventative maintenance and trouble-shooting of site utilities is required.
5. Experience in equipment commissioning, qualification, and validation programs is required.
6. Sound knowledge of Good Manufacturing Practices including NMPA, PIC/S, and US-FDA guidelines with focus on API and/or sterile product manufacture;