Engineering Manager - Pharma - Pune

Emcure Pharmaceuticals Limited; Pune District; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Emcure Pharmaceuticals Limited is seeking an Engineering Operations & Maintenance lead for its sterile manufacturing facilities in India. The role focuses on ensuring equipment reliability, regulatory compliance, asset lifecycle management, and uninterrupted production support for PFS, ADC and vial filling lines.

You will oversee maintenance strategy, utilities, validations, and safety across multiple lines.

Responsibilities

• Lead preventive, predictive, breakdown and reliability maintenance for sterile manufacturing equipment.
• Ensure high equipment uptime and efficiency across PFS lines, vial filling/stoppering lines, isolators, lyophilizers, autoclaves, CIP/SIP systems, VIS and packaging equipment.
• Monitor KPIs such as MTBF, MTTR, OEE and downtime; ensure maintenance compliance.
• Manage critical utilities including HVAC, PW & WFI water systems, clean steam generators, compressed air, chillers and EMS/BMS systems.
• Support regulatory audits and customer inspections; ensure documentation alignment with MHRA/EU GMP/WHO GMP/Schedule M requirements.
• Lead DQ/IQ/OQ/PQ activities and equipment/utility qualification; coordinate with QA and production teams on qualification projects.
• Drive capex projects, vendor selection, budgeting and execution; pursue automation and digitalization to improve efficiency.
• Lead and develop engineering teams, conduct performance reviews and ensure GMP and safety practices.

Job description

To lead engineering operations and maintenance activities for Sterile Manufacturing facilities, ensuring maximum equipment reliability, regulatory compliance, asset lifecycle management, and uninterrupted production support for PFS (Pre-Filled Syringes), ADC (Antibody Drug Conjugate), and Vial Filling Lines.

Engineering Operations & Maintenance

• Lead preventive, predictive, breakdown, and reliability maintenance activities for sterile manufacturing equipment.
• Ensure high equipment uptime and operational efficiency of:
  • Pre-Filled Syringe (PFS) Lines
  • Vial Filling & Stoppering Lines
  • Isolators and RABS Systems
  • Lyophilizers
  • Autoclaves
  • CIP/SIP Systems
  • Visual Inspection Machines
  • Packaging Equipment
• Monitor engineering KPIs such as MTBF, MTTR, OEE, downtime, and maintenance compliance.

Utilities & Facility Management

• Manage critical utilities including:
  • HVAC Systems
  • Water Systems (PW & WFI)
  • Pure Steam Generators
  • Compressed Air Systems
  • Chillers & Cooling Towers
  • Electrical Distribution Systems
  • BMS & EMS Systems
• Ensure uninterrupted utility support for sterile manufacturing operations.

Regulatory & Compliance Management

• Ensure compliance with:
  • MHRA
  • EU GMP
  • WHO GMP
  • Schedule M
  • Data Integrity Requirements
• Support and lead engineering activities during regulatory audits and customer inspections.
• Ensure compliance of maintenance and engineering documentation.

Qualification & Validation

• Lead execution of:
  • DQ, IQ, OQ and PQ activities
  • Equipment Qualification
  • Utility Qualification
  • Facility Qualification
• Support Validation, Quality Assurance and Production teams during qualification projects.

Projects & Automation

• Lead installation, commissioning, qualification, and startup of new equipment and facilities.
• Manage capex projects, vendor selection, budgeting, and execution.
• Drive automation and digitalization initiatives to improve operational efficiency.

Team Management

• Lead and develop engineering team members, supervisors, and technicians.
• Conduct performance reviews, capability development and succession planning.
• Ensure adherence to safety and GMP practices across the engineering team.

EHS & Risk Management

• Ensure compliance with safety standards and engineering best practices.
• Participate in risk assessments, HAZOP studies, and investigation of engineering-related deviations.

Desired Experience

• Experience in regulated pharmaceutical companies such as Injectable, Biologics, Sterile, Vaccine, PFS, or ADC manufacturing facilities.
• Hands-on exposure to filling lines
• Experience handling engineering support for sterile facilities inspected by MHRA, EMA or equivalent regulatory bodies.

Preferred Industry:

Injectable, Biologics, Vaccines, Oncology, ADC, Sterile Pharma Manufacturing Facilities.