Head Engineer - Sterile Facilities

Synokem Pharmaceuticals; Sirmaur; On-site; INR 3,500,000 - 9,000,000; Full time

Job summary

Synokem Pharmaceuticals seeks an accomplished Senior Engineering Leader to oversee Engineering, Maintenance, Utilities and Projects for two injectable manufacturing units. You will drive GMP compliance for sterile/parenteral and ophthalmic facilities, lead HVAC, cleanroom zoning and critical utilities, and manage EMS/BMS strategies and data integrity initiatives.

Responsibilities include coordinating FAT/SAT, QMS-aligned validation, and CAPEX projects from URS to handover, ensuring energy

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.

Job description

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.