About the role
The Shift Engineer is responsible for the smooth and uninterrupted operation of all plant machinery, utilities, and facility systems during their designated shift. This role ensures that all engineering activities comply with strictly regulated pharmaceutical standards (cGMP, FDA, MHRA), while minimizing equipment downtime and ensuring a safe working environment. Execute Preventive Maintenance (PM) and Breakdown Maintenance of process and Utility equipment. Operate and maintain critical pharma utilities, including HVAC systems, Purified Water (PW), Water for Injection (WFI), Pure Steam generators, chillers, and air compressors. Diagnose and troubleshoot mechanical, electrical, and pneumatic issues on the shop floor to minimize production downtime. Monitor Building Management Systems (BMS) and Environmental Management Systems (EMS) to ensure cleanroom temperatures, humidity, and differential pressures remain within acceptable limits. 2. Compliance & Documentation Ensure all engineering work is executed in strict adherence to cGMP (Current Good Manufacturing Practice) and standard operating procedures (SOPs). Complete all maintenance logbooks, breakdown reports, and PM checklists in real-time, adhering to ALCOA+ data integrity principles. Assist in equipment qualification (IQ/OQ/PQ) and validation activities. Participate in root cause analysis (RCA) and implement Corrective and Preventive Actions (CAPA) for engineering deviations. 3. Shift Management & Safety Conduct seamless shift handovers, ensuring the incoming shift is fully briefed on equipment status, ongoing repairs, and utility conditions. Supervise and guide fitters, electricians, and utility operators working during the shift. Ensure strict compliance with environmental, health, and safety (EHS) protocols, including the Lockout/Tagout (LOTO) system and Permit to Work (PTW) procedures. Qualifications & Experience Education: Bachelor’s Degree (B.Tech/B.E.) or Diploma in Electrical, Engineering. Experience: 3 to 7 years of hands-on maintenance and utility experience within a pharmaceutical manufacturing environment (API, Formulations, or Biologics). Willingness to Work Shifts: Must be comfortable working in a 24/7 rotational shift environment, including nights and weekends. Technical Knowledge: Strong understanding of pharmaceutical process equipment, cleanroom HVAC, and critical water systems (WFI/PW). Automation Familiarity: Basic troubleshooting knowledge of PLCs, SCADA, and HMI systems. Regulatory Acumen: Solid understanding of global pharmaceutical regulatory guidelines and audit readiness. Problem Solving: Ability to work under pressure, make quick technical decisions, and resolve sudden breakdowns efficiently.