Sr. Manager - Utilities Lead - Pharma Formulation (OSD) @Ambernath

Rubicon Research; Mumbai, Ambernath; On-site; INR 1,800,000 - 2,500,000; Full time

Job summary

Rubicon Research is seeking a Lead Utilities to oversee all critical utility systems within a pharmaceutical formulations manufacturing plant in Mumbai. The role leads a team of engineers and technicians, ensuring uninterrupted operations, regulatory compliance, and audit readiness under USFDA, MHRA, and WHO guidelines.

The candidate will drive preventive and predictive maintenance, manage CAPEX projects, and coordinate cross-functionally with Production, QA, EHS, and Supply Chain to resolve

Qualifications

• Pharma utilities mastery over PW/WFI, HVAC, steam networks, and power distribution grids.
• Proven competency in preparing engineering documentation and defending data with USFDA/MHRA auditors.
• Experience steering mechanical installation projects from design through IQ/OQ/PQ validation.
• Background in predictive maintenance, failure mode tracking, and safety systems.
• Strong planning, communication, and troubleshooting to lead a multi-layered utility department.

Responsibilities

• Lead and manage the utilities function, ensuring 100% uninterrupted operations to support manufacturing lines.
• Oversee daily operation and maintenance of critical PW/WFI, HVAC networks, DG sets, and power distribution.
• Drive preventive, predictive, and breakdown maintenance schedules to minimize downtime.
• Direct all utility CAPEX projects including planning, installation, commissioning, and validation.
• Lead audits by USFDA, MHRA, and WHO as the subject matter expert for plant engineering and utilities.
• Maintain SOPs, qualification documents, validation protocols, and GMP records.
• Monitor plant performance metrics and drive energy conservation and cost optimization.
• Mentor and develop a team of utility engineers, supervisors, and operators.
• Coordinate with Production, QA, EHS, and Supply Chain to resolve issues.
• Enforce cGMP, LOTO safety, and environmental compliance across utilities blocks.

Skills

Pharma utilities mastery

Audit & compliance defensibility

Project management & lifecycle

Strategic reliability & EHS

Stature & team leadership

Education

B.Tech / B.E. in Mechanical, Electrical, or Instrumentation Engineering

Job description

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.