Engineering Manager

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.