Key Responsibilities
System Operations & Maintenance: Manage daily operations of HVAC systems, clean rooms, pure steam generators, chillers, and water systems like Purified Water (PW) and Water for Injection (WFI).
Compliance & Documentation: Ensure all activities strictly follow current Positive Manufacturing Practices (cGMP), Good Engineering Practices (GEP), and site safety rules.
Preventive Maintenance: Execute planned preventive and breakdown maintenance programs to minimize equipment downtime.
Qualification & Validation: Support installation, commissioning, and qualification (IQ/OQ/PQ) protocols for current and existing utility equipment.
Cross-Functional Coordination: Coordinate with internal production groups, quality assurance teams, and external vendors for repairs or project upgrades.
Resource & Energy Optimization:
Monitor energy consumption, track spare parts inventory, and troubleshoot system anomalies using root cause analysis.
Qualifications & Requirements
Education: Bachelor’s degree or Diploma in Mechanical, Chemical, or Electrical Engineering.
Experience: 3 to 6 years of hands-on experience in a pharmaceutical, biotech, or cGMP-regulated manufacturing plant.
Technical Skills: Solid knowledge of HVAC design, P&IDs; (Piping and Instrumentation Diagrams), water purification loops, and Building Management Systems (BMS).