Engineering Manager

Emcure Pharmaceuticals Limited; Pune District; On-site; INR 3,500,000 - 6,000,000; Full time

Job summary

Emcure Pharmaceuticals Limited in Pune district seeks a senior engineering leader to drive operations and maintenance for sterile manufacturing facilities, ensuring equipment reliability and uninterrupted production for PFS, ADC, and vial filling lines.

You will oversee preventive, predictive, and breakdown maintenance, monitor MTBF/MTTR/OEE, manage utilities, support regulatory audits, and lead qualification and automation initiatives with GMP and data integrity at the forefront.

Qualifications

• Experience in regulated pharmaceutical manufacturing facilities.
• Hands-on exposure to sterile filling lines and related equipment.
• Experience handling MHRA/EMA/WHO compliance expectations.

Responsibilities

• Lead preventive, predictive, breakdown and reliability maintenance for sterile manufacturing equipment to ensure high uptime and efficiency.
• Oversee utilities and facilities management including HVAC, water systems, clean utility supplies and electrical distribution.
• Support regulatory audits and customer inspections; ensure maintenance documentation compliance and data integrity.
• Lead DQ/IQ/OQ/PQ activities and equipment, utility, and facility qualifications; coordinate with QA and Production teams during qualification projects.
• Drive automation and digitalization initiatives to improve operational efficiency and capex project delivery.
• Manage and develop the engineering team, ensuring safety, GMP practices, and performance Reviews.

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.