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 transparent ownership across utilities

📌 Head Engineer (Paonta Sahib)
🏢 Synokem Pharmaceuticals
📍 Paonta Sahib