Engineering Head (API Pharmaceutical Manufacturing)

Role & responsibilities

• Lead and manage the overall Engineering, Maintenance, Utilities, Electrical, Instrumentation and Project activities of the API manufacturing facility.
• Ensure maximum availability, reliability and efficient performance of plant machinery, equipment and critical utilities.
• Develop and implement preventive, predictive and breakdown maintenance programs to minimize equipment downtime.
• Ensure proper maintenance of API process equipment such as reactors, centrifuges, dryers, filters, pumps, vacuum systems and other critical equipment.
• Ensure reliable operation and maintenance of utilities including HVAC, chillers, boilers, compressors, DG sets, cooling towers, water systems, vacuum and nitrogen systems.
• Plan and execute new projects, plant modifications, capacity expansions, equipment installation, commissioning and facility development within approved timelines and budgets.
• Review and approve URS, technical specifications, engineering drawings, vendor proposals and project-related documents.
• Ensure compliance with cGMP, WHO-GMP, USFDA, EU/EDQM and other applicable regulatory requirements related to Engineering and Maintenance.
• Lead engineering-related activities during regulatory, customer and certification audits and ensure timely closure of observations and CAPA.
• Drive energy conservation and cost optimization initiatives for electricity, fuel, water and other utilities.
• Prepare and manage the annual Engineering/Maintenance budget and control expenditure against approved budgets.
• Lead, develop and motivate the Engineering, Maintenance, Utilities, Electrical and Instrumentation teams through effective manpower planning, training and performance management.
• Evaluate and manage contractors, consultants, equipment suppliers and service providers to ensure quality, timely execution and cost effectiveness.

Preferred candidate profile

• 15 to 20+ years of relevant experience in Engineering/Maintenance in an API pharmaceutical manufacturing company.
• Candidates from API / bulk drug manufacturing background will be preferred.

Interested candidates with relevant experience in API pharmaceutical manufacturing may apply with their updated CV. or send the resume on [email protected]