Engineering Manager - Pharma - Pune

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.