The Head of Engineering owns end-to-end engineering performance at Knovea's Indore injectable manufacturing facility from equipment reliability (Isolators, Powder and liquid fill machines, Lyophilisers, others..) and critical utilities (boilers, HVAC, WFI/pure steam, compressors, DG sets and others..) to GMP compliance, regulatory audit readiness, and CAPEX/OPEX budget management.

Key Responsibilities

Maintenance & Equipment Reliability

- Ensure effective planning, scheduling, and execution of preventive maintenance for all plant equipment.
- Ensure timely and effective breakdown maintenance of all plant equipment.
- Maintain minimum required inventory of spares for all plant equipment.
- Plan, schedule, and allocate work across the team, ensuring timely completion and effective utilization of manpower.
- Investigate all equipment/process failures and ensure corrective and preventive actions (CAPA) related to Engineering.
- Maintain a visible, hands-on presence on the shop floor personally involved in critical maintenance activities, breakdowns, and escalations rather than managing remotely.

Utilities & Critical Systems

- Own end-to-end operation, maintenance, and reliability of critical utilities including boilers, compressors, DG sets, HVAC/AHUs, water systems (WFI/pure steam), and other critical plant infrastructure.
- Ensure statutory compliance and safe operation of all pressure equipment and utility systems (boiler certification, pressure vessel inspections, etc.).
- Drive uptime and efficiency improvements across utility systems through preventive monitoring and timely intervention.

Compliance & Safety

- Ensure GMP and safety systems are strictly followed during all work execution, with zero GMP violations.
- Drive safety awareness across the team and ensure attendance at HSE training.
- Train and develop subordinates on current regulatory requirements and good engineering practices.

Regulatory & Audit Management





- Lead engineering readiness and represent Engineering during regulatory inspections and audits (USFDA, EU-GMP, WHO-GMP, and other applicable bodies).
- Ensure timely closure of audit observations and CAPAs related to engineering and utility systems.
- Maintain qualification, calibration, and validation documentation for critical equipment and utilities in an audit-ready state at all times.

Budget & Cost Ownership

- Own and manage the annual Engineering CAPEX and OPEX budget, including planning, approvals, and variance tracking.
- Drive reduction in revenue budget spend, material loss, and energy consumption (power, fuel, water, consumables, etc.).
- Identify and implement automation, mechanization, and digitization opportunities to improve quality compliance and productivity.

Digital Systems & Documentation

- Drive adoption and effective use of CMMS/digital maintenance systems (e.g., SAP PM or equivalent) for planning, tracking, and reporting maintenance activities.
- Oversee material management, bill tracking and reconciliation, and documentation.

Projects & Vendor Management

- Lead selection and technical evaluation of engineering equipment, and validate vendor recommendations.
- Coordinate with consultants and vendors for smooth design, execution, and closure of projects.
- Track project plans, CAPEX, and schedules; escalate issues to the Plant Head as needed.
- Coordinate with government authorities for statutory and regulatory approvals.

Team & Stakeholder Management

- Build strong working relationships with cross-functional and interdepartmental teams (Production, Quality, and others)



— demonstrating genuine teamwork spirit beyond the Engineering function.
- Lead transparent, effective communication and discussions with domestic and international stakeholders, including vendors, consultants, and regulatory bodies.
- Manage internal and external communication related to engineering operations.
- Forecast workload and manage work progress within the function; prioritize tasks, delegate work, and ensure timely delivery.

Qualifications & Experience

- B.E./B.Tech in Mechanical/Electrical/Instrumentation Engineering (or equivalent); M.E./M.Tech preferred but not mandatory.
- Injectable manufacturing experience is mandatory — prior experience in a sterile/injectable pharmaceutical manufacturing facility including Isolators, Dry Powder Fill, meant for regulated markets is a must-have, not just preferred.
- Prior experience in a regulated (pharma/GMP) manufacturing environment, specifically injectables, is required.
- Demonstrated experience managing CAPEX/OPEX budgets, vendor relationships, and statutory/regulatory approvals in a sterile manufacturing setup.
- Proven experience handling regulatory audits (USFDA/EU-GMP/WHO-GMP) from an engineering standpoint.

Key Skills

- Preventive & breakdown maintenance planning
- GMP/HSE compliance
- CAPEX/OPEX budget ownership and cost control
- Utilities and critical systems management (boilers, HVAC, WFI/pure steam, compressors, DG sets)
- CMMS/digital maintenance systems (SAP PM or equivalent)
- Regulatory audit readiness and management
- Vendor and consultant management
- Hands-on, shop-floor leadership style
- Cross-functional teamwork and stakeholder management
- Sterile/aseptic area engineering (cleanroom qualification, environmental monitoring)
- Excellent communication skills, with the ability to lead discussions and negotiations with both domestic and international stakeholders

📌 Engineering Head (Indore)
🏢 Knovea Pharmaceutical
📍 Indore