Head Engineering

Job Description

Role & responsibilities Lead and manage the Engineering department with a focus on Process Engineering and Utilities. Plan, design, and implement engineering systems to support sterile and non-sterile pharmaceutical manufacturing. Ensure uninterrupted operation and compliance of all utility systems including HVAC, WFI, clean steam, compressed air, chilled water, and effluent treatment. Develop and implement SOPs for engineering operations, preventive maintenance, and calibration. Ensure compliance with cGMP, GEP, and regulatory requirements for all engineering activities. Lead capital projects including facility upgrades, equipment installation, and utility expansions. Coordinate with QA, Production, and Validation teams for timely execution of qualification and validation activities. Monitor and control energy consumption and implement energy-saving initiatives. Ensure timely execution of preventive and breakdown maintenance for all equipment and utilities. Lead root cause analysis and implement CAPA for engineering-related deviations and failures. Ensure readiness for regulatory inspections and audits by maintaining documentation and compliance. Develop and manage engineering budgets, procurement plans, and vendor management. Lead the recruitment, training, and development of engineering personnel. Ensure safety practices are followed across all engineering operations. Drive continuous improvement initiatives in process efficiency, equipment reliability, and utility performance. Ensure timely review and approval of engineering documents including URS, DQ, IQ, OQ, PQ, and validation protocols. Should have Knowledge on TPM Principless Drive Asset Robustness Program with Energy Efficiency. Coordinate with external agencies for statutory compliance related to utilities and infrastructure. Ensure proper documentation and control of engineering records and drawings. Support technology transfer and scale-up activities from R&D to commercial production. Any other assignment given by higher management. Preferred candidate profile Educational qualification : B.E./Btech or M.E./M.Tech in Mechanical, Electrical, Chemical, or related engineering discipline. Minimum work experience: 15 to 20 years in pharmaceutical manufacturing with strong exposure to sterile operations and utility systems. Skills & attributes: Technical Skills Expertise in utility systems (HVAC, WFI, clean steam, etc.) and process equipment. Experience in project management, equipment qualification, and validation. Knowledge of regulatory requirements (USFDA, EU GMP, WHO, etc.). Familiarity with engineering documentation and QMS systems. Hands-on experience in energy management and automation systems. Behavioural skills Strong leadership and team management capabilities. Excellent problem-solving and decision-making skills. Effective communication and cross-functional collaboration. High attention to detail and commitment to compliance and safety.