Senior Manager – Engineering & Maintenance

The Senior Manager – Engineering & Maintenance is responsible for leading and managing the maintenance activities of process equipment, HVAC systems, and clean utility systems to ensure optimal performance, compliance with regulatory standards, and uninterrupted operations. This role involves strategic planning, team leadership, and cross-functional collaboration to support manufacturing and facility operations.

Key Responsibilities:

1. Process Equipment Maintenance

Oversee preventive, predictive, and corrective maintenance of all manufacturing and process equipment.

Ensure equipment reliability and availability to meet production targets.

Lead root cause analysis and implement corrective actions for equipment failures.

Maintain equipment history and documentation

Coordinate with production and quality teams for equipment qualification and validation.

2. HVAC System Management

Manage operations and maintenance of HVAC systems including AHUs, chillers, ducting, and BMS.

Ensure compliance with cleanroom environmental conditions (temperature, humidity, pressure differentials).

Monitor HVAC performance and implement energy-efficient practices.

Lead HVAC system upgrades and modifications as per GMP and regulatory requirements.

3. Clean Utility Systems

Supervise maintenance of clean utilities such as purified water, WFI, clean steam, compressed air, and nitrogen systems.

Ensure consistent utility quality and availability for manufacturing operations.

Conduct periodic audits and ensure compliance with pharmacopeial standards.

Collaborate with validation and QA teams for utility system qualification and requalification.

Leadership & Compliance

Lead a team of engineers and technicians; provide training and development.

Ensure compliance with cGMP, EHS, and regulatory standards.

Prepare and manage engineering budgets and maintenance KPIs.

Support audits (internal, external, regulatory) and implement CAPAs.

Qualifications & Experience:

Bachelor's or Master's degree in Mechanical/Electrical Engineering.

Minimum 10+ years of experience in pharmaceutical/biotech/FMCG industry.

Strong knowledge of GMP, HVAC, clean utilities, and process equipment.

Experience in managing cross-functional teams and engineering projects.

Proficiency in, AutoCAD, and MS Office tools.

Key Skills:

Technical expertise in equipment and utility systems

Leadership and team management

Problem-solving and decision-making

Project management

Regulatory compliance and documentation