Manager Engineering

Job Responsibilities:

• Engineering Operations & Maintenance Oversee engineering and maintenance functions for API operations, ensuring smooth plant performance and compliance with USFDA, EU GMP, and MHRA regulations.
• Plan, execute, and monitor preventive and predictive maintenance programs for critical equipment, utilities, and containment systems. Regulatory Compliance & Audit Readiness
• Ensure audit readiness through effective equipment qualification, validation, and documentation practices.
• Support and participate in regulatory audits including USFDA audits, ensuring timely compliance and closure of observations.
• Ensure compliance of containment systems, HVAC with BIBO, isolators, wet scrubbers, and OEL study protocols with regulatory and safety requirements.
• Projects & Facility Upgradation Execute expansion, upgradation, and modernization projects for API facilities, particularly involving cytotoxic manufacturing and containment technologies.
• Support CAPEX planning and execution, ensuring projects are completed within approved budgets and timelines.
• Implement energy efficiency, sustainability, and automation initiatives across engineering operations.
• Utilities & Equipment Management Manage utilities including HVAC (BIBO systems), purified water, compressed air, and effluent treatment systems.
• Ensure optimal performance and maintenance of reactors, clean rooms, manufacturing equipment, and cytotoxic handling systems. Safety, Environment & Compliance Ensure strict adherence to HSE policies and environmental regulations, including hazardous waste management and containment validation.
• Drive safe engineering practices to minimize occupational exposure risks and maintain OEL compliance.
• Coordination & Operational Support Work closely with Production, Quality, EHS, and external vendors to ensure seamless engineering support.
• Provide technical support during equipment installation, commissioning, troubleshooting, and operational improvements.

Qualification required:

B.E. / B.Tech in Engineering (Mechanical / Electrical / Chemical or relevant discipline)

Experience Required

10-15 years of relevant experience in Engineering & Maintenance within regulated API / Life Sciences manufacturing facilities. Hands-on experience with cytotoxic product equipment, containment systems, HVAC with BIBO, isolators, wet scrubbers, and OEL studies. Exposure to USFDA-regulated facilities and audits is mandatory.

Skills & Competencies:

Strong knowledge of engineering maintenance and containment technology Expertise in regulatory compliance (USFDA, EU GMP) Experience in CAPEX execution and facility upgradation Sound understanding of utilities, HVAC (BIBO), and environmental systems Strong team coordination, problem-solving, and communication skills Focus on safety, compliance, and continuous improvement