AM/Manager Engineering Operations & Maintenance - Sterile - Pune

Job Description Engineering Manager (Sterile Manufacturing)

Position: Engineering Manager
Department: Engineering
Location: Pune
Qualification: B.E. / B.Tech (Mechanical, Electrical, Instrumentation or Equivalent)
Experience: Minimum 10 Years in Pharmaceutical Manufacturing Engineering, including at least 2 Years in a Managerial Role within a Regulated Pharmaceutical Company.

Job Purpose

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.

Key Responsibilities

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.

Key Skills

• Sterile Manufacturing Engineering
• PFS, ADC & Vial Line Operations
• HVAC & Cleanroom Systems
• WFI & Pure Steam Systems
• Equipment Qualification & Validation
• CAPEX Project Management
• Reliability Engineering
• GMP Compliance
• Regulatory Audit Handling
• Team Leadership
• Root Cause Analysis
• SAP PM / CMMS

Reporting

Reports To: Engineering Head

Team Size

Managing Engineering Team comprising Engineers, Supervisors, Technicians and Utility Personnel.

Preferred Industry: Injectable, Biologics, Vaccines, Oncology, ADC, Sterile Pharma Manufacturing Facilities.