Role & responsibilities Purpose The Lead Utilities is responsible for ensuring the reliable, efficient, compliant, and uninterrupted operation of all critical utility systems within a regulated pharmaceutical formulations manufacturing plant. This role spearheads engineering projects, cost-optimization programs, and maintenance strategies while leading a team of engineers and technicians to guarantee a continuous state of audit readiness under USFDA, MHRA, and WHO guidelines. Responsibilities
- Lead and manage the overall Utilities function, ensuring 100% uninterrupted operations to support non-stop commercial manufacturing lines.
- Oversee the daily operation, continuous monitoring, and strategic maintenance of critical black and clean utilities, including:
- Boiler & Steam Generation Systems, Chillers, and Cooling Towers.
- Purified Water (PW) and Water for Injection (WFI) Generation and Distribution Loops.
- Nitrogen Generation Plants, Compressed Air Systems, and HVAC/AHU networks.
- Diesel Generator (DG) Sets, Power Distribution Networks, ETP, and WTP systems.
- Drive effective preventive, predictive, and breakdown maintenance schedules for all utility equipment to eliminate unplanned downtime.
- Direct all utility-related capital engineering projects (CAPEX), including long-term planning, installation, commissioning, qualification, and validation.
- Front-face major international regulatory audits (USFDA, MHRA, WHO) individually as the subject matter expert for plant engineering and utilities.
- Manage the compilation, review, and lifecycle of all utility-related SOPs, qualification documents, validation protocols, and GMP maintenance records.
- Monitor plant-wide performance metrics, implementing structured energy conservation, equipment reliability, and utility cost-optimization initiatives.




- Mentor and develop a highly capable team of utility shift engineers, supervisors, and core technical plant operators.
- Coordinate cross-functionally with Production, Quality Assurance, EHS, and Supply Chain Management to resolve complex quality events or engineering failures.
- Enforce absolute adherence to cGMP requirements, workplace safety procedures (LOTO), and environmental compliance norms across utility blocks. Required Skills
- Pharma Utilities Mastery: Deep technical operational command over high-capacity clean water loops (PW/WFI), industrial HVAC cascades, steam networks, and complex power distribution grids.
- Audit & Compliance Defensibility: Proven expert competency in preparing engineering documentation, tracking logbooks, and defending data integrity parameters to USFDA and MHRA auditors.
- Project Management & Lifecycle: Skilled in steering mechanical installation projects from engineering design through validation testing stages (IQ/OQ/PQ).
- Strategic Reliability & EHS: Experienced in using predictive maintenance engineering tools, running failure mode tracking, and executing robust safety systems.
- Stature & Team Leadership: Strong planning, communication, and troubleshooting capabilities needed to direct a multi-layered engineering asset department. Preferred Candidate Details
- Core Industry Domain: Must be currently working in a heavily regulated Pharmaceutical Formulations (OSD) manufacturing facility managing large-scale infrastructure.
- Academic Background: Full time B.
Tech / B.
E. in Mechanical, Electrical, or Instrumentation Engineering from an accredited technical university.
- Leadership Tenure: Demonstrated capability of leading large-scale utility infrastructures and independent management of direct technical engineering panels.
- Joining Notice: Candidates who are immediate joiners or possess short notice periods will be given an immediate operational preference.

📌 Sr. Manager (Mumbai)
🏢 Rubicon Research
📍 Mumbai