Be responsible for the operation and maintenance of BMS and EMS systems, such as configure, troubleshoot and optimize BMS control strategies
Monitor system performance and investigate alarms, events, and system abnormalities
Prepare, review, and maintain GMP documentation, such as SOPs, maintenance records, system configuration records, risk evaluation files. Ensure all documentation is complete, accurate, contemporaneous, and attributable in accordance with ALCOA principles.
Participate in the investigation of quality events related to BMS and EMS, such as deviation, change control, CAPA. Ensure timely completion of quality events and action items.
Participate in internal audits and customer audits, provide technical support during inspections, address audit observations and support remediation activities.
About You:
Bachelor’s degree or above in automation engineering, electrical engineering, mechanical engineering or other HVAC related major
Minimum 3-5 years of experience in supporting BMS, EMS, HVACin pharmaceutical industry.
Understand GMP regulations, data integrity requirements, good documentation practices.
Have practical experience with deviations, CAPA, change controls, risk assessments, regulation inspections.