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 recent 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.

📌 Engineering Manager (Pune)
🏢 Emcure
📍 Pune