Head Of Engineering(Pharma)

1 week ago

Odhav, India Talent Sutra Full time

About the RoleThe Engineering Head is a senior leadership role responsible for the strategic planning, direction, and execution of all engineering activities, including facilities maintenance, utilities operation, capital projects, and equipment qualification/validation, to ensure safe, compliant, and efficient pharmaceutical manufacturing operations.ResponsibilitiesLeadership and Management: Lead and manage the entire Engineering Department, including maintenance, utilities, and project teams (personnel such as Kailash, Dhanvir, Mehul, Jignesh, Nilesh, Sameer, Shakil, Shaukat, Jitender, and Suryakant as mentioned in the organogram).Develop and mentor staff to enhance technical skills and adherence to Good Engineering Practices (GEP) and Good Manufacturing Practices (GMP).Manage the departmental budget, control expenditures, and optimize resource allocation.Maintenance and Utilities Management: Oversee the Production Maintenance activities, ensuring minimal downtime and operational efficiency (as performed by Mehul and Shakil).Direct the operation, maintenance, and reliability of all critical utility systems, including Water systems, HVAC, Chiller, Boiler, and Air Compressors.Establish and manage the Preventive Maintenance (PM) and Calibration programs for all production equipment and instruments.Ensure compliance with safety regulations and environmental standards for all utility operations.Compliance and Quality Assurance: Act as the primary engineering liaison with the Quality Assurance department (Kailash and Dhanvir are listed with Quality and Project Head roles).Ensure all engineering activities, documentation (supported by Suryakant), and systems comply with cGMP, FDA, WHO, and other regulatory guidelines.Oversee the execution of Qualification and Validation protocols for equipment, facilities, and utilities (IQ/OQ/PQ).Manage the engineering response to audits, deviations, Change Controls, and CAPAs.Project and Capital Management: Plan, execute, and oversee Capital Expenditure (CAPEX) projects, including new facility construction, equipment installation, and system upgrades.Ensure projects are completed on time, within budget, and meet all technical and regulatory requirements.Manage vendors, contractors, and consultants for outsourced engineering and construction work. QualificationsEducation: Bachelor’s or Master’s degree in Mechanical, Electrical, Chemical, or Industrial Engineering.Experience: Minimum of 10-15 years of progressive experience in the pharmaceutical industry (or a highly regulated equivalent), with at least 5 years in a senior leadership or management role.Technical Skills: Deep knowledge of utility systems (HVAC, Purified Water, Clean Steam, Compressed Air), facility design, maintenance programs, and automation.Regulatory Knowledge: Expert understanding of cGMP, GEP, and international regulatory requirements (e.G., FDA, MHRA, WHO).

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