Head Engineer - Sterile Facilities

Role & Responsibilities

• Lead Engineering, Maintenance, Utilities, Projects and Technical Services for two injectable manufacturing units with multiple production lines.
• Provide engineering leadership for sterile/aseptic and ophthalmic manufacturing areas, including DPI, ampoules, liquid vials and ophthalmic products.
• Ensure compliance with Revised Schedule M, GMP and regulatory requirements for sterile/parenteral and ophthalmic facilities.
• Lead HVAC/AHU, cleanroom zoning, pressure differentials, temperature/RH control, HEPA filtration, air balancing, room classification and requalification activities.
• Own EMS/BMS strategy, including environmental monitoring, alarm management, data trending, access controls, audit trails and data integrity.
• Ensure qualification, validation and lifecycle management of critical utilities including PW/WFI, pure steam, compressed air, nitrogen, vacuum, chilled water, cooling towers, boilers, DG and electrical systems.
• Ensure engineering readiness and compliance of autoclaves/sterilizers, depyrogenation tunnels, filling machines, lyophilizers, cold rooms and other critical sterile manufacturing equipment.
• Establish robust preventive and predictive maintenance, calibration, breakdown reduction, spare-parts management and engineering KPI systems.
• Lead engineering support for GMP audits, regulatory inspections and customer audits, including CAPA and observation closure.
• Drive FAT, SAT, IQ/OQ support, qualification/requalification, change controls, deviations, CAPA, risk assessments and engineering documentation in coordination with QA and Validation.
• Lead CAPEX and expansion projects from URS, design review and vendor selection through FAT, installation, commissioning, qualification and handover.
• Drive energy, water and utility optimization while maintaining GMP, sterility assurance, EHS and product quality requirements.
• Build and develop a technically competent engineering team with clear ownership across utilities, maintenance, projects, automation and engineering documentation.
• Ensure statutory compliance, engineering safety, emergency preparedness, AMC/service contracts and critical spares availability.
• Act as the site engineering authority for contamination control systems, supporting CCS and QRM initiatives in collaboration with QA and Manufacturing.