Engineering Head (API Pharmaceutical Manufacturing)

Praveen Laboratories; Surat; On-site; INR 5,000,000 - 8,000,000; Full time

Job summary

Praveen Laboratories seeks a senior Engineering and Maintenance leader to oversee API plant functions, including engineering, utilities and project delivery. You will ensure equipment reliability, implement preventive maintenance and drive CAPA during audits.

The role requires extensive API/bulk drug manufacturing experience, strong budget control and team development, with a focus on energy optimization and regulatory compliance across cGMP and international standards.

Qualifications

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

Responsibilities

• Lead and manage Engineering, Maintenance, Utilities, Electrical, Instrumentation and Project activities of the API manufacturing facility.
• Ensure maximum availability, reliability and efficient performance of plant machinery and critical utilities.
• Develop and implement preventive, predictive and breakdown maintenance programs to minimize equipment downtime.
• Maintain API process equipment such as reactors, centrifuges, dryers, filters, pumps, vacuum systems and other critical equipment.
• Ensure reliable operation of HVAC, chillers, boilers, DG sets, water systems and other utilities.
• Plan and execute new projects, capacity expansions, equipment installation, commissioning within budgets.
• Review URS, technical specs, drawings, vendor proposals, project docs.
• Ensure compliance with cGMP, WHO-GMP, USFDA, EU/EDQM and other regulatory requirements.
• Lead engineering activities during audits and CAPA closure.
• Drive energy conservation and cost optimization for utilities.
• Prepare and manage annual Engineering/Maintenance budget and control expenditures.
• Lead, develop and motivate Engineering teams through manpower planning and training.
• Evaluate and manage contractors and vendors for quality and cost effectiveness.

Skills

Leadership

Maintenance management

Project management

Regulatory compliance

Budget planning

Team development

Equipment optimization

Job description

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.