General Manager Engineering And Projects

Immacule Life Sciences; Solan; On-site; INR 3,500,000 - 5,500,000; Full time

Job summary

Immacule Life Sciences in India seeks a Senior Engineering Manager to lead Engineering, Process Equipment, Utilities, Maintenance, and Projects for a sterile injectable manufacturing facility. You will ensure equipment reliability, regulatory compliance, and successful execution of infrastructure development and capacity expansion.

You will oversee installation, qualification, validation, and maintenance of process equipment and utilities, manage CAPEX budgets, coordinate with QA, Production,

Qualifications

• Bachelor's degree in Mechanical Engineering; relevant qualifications preferred.
• 1825+ years of experience in pharmaceutical engineering with sterile injectable exposure.
• Proven senior leadership in Engineering, Process Equipment, Utilities, Maintenance and Projects.
• Strong GMP, regulatory knowledge, and CAPEX management experience.

Responsibilities

• Lead Engineering, Process Equipment, Utilities, Maintenance and Projects for sterile injectable facility.
• Ensure equipment reliability, uptime, and regulatory compliance.
• Oversee installation, commissioning, qualification, validation, and maintenance.
• Manage preventive, predictive, and breakdown maintenance; lead RCA and CAPA.
• Drive greenfield/brownfield projects, capacity expansion, and equipment upgrades.
• Review specifications, URS, PFDs, P&IDs, designs, and estimates.
• Coordinate CAPEX budgeting, procurement, vendor selection, and timelines.
• Oversee FAT/SAT, erection, commissioning, and performance verification.
• Ensure cGMP/WHO-US/EU GMP compliance; audit readiness.
• Maintain engineering docs, calibration records, and preventive maintenance schedules.
• Monitor spare parts, energy use, and maintenance expenditure.
• Foster continuous improvement and collaborate with QA, Production, Validation, EHS, Procurement.
• Lead and develop Engineering, Utilities, Maintenance and Projects teams.

Skills

Sterile injectable process equipment

Engineering leadership

GMP compliance

CAPEX and project management

Maintenance and RCAs

Education

Bachelor's in Mechanical Engineering

Tools

Aseptic filling lines

FAT/SAT/IQ/OQ/PQ

HVAC and cleanroom systems

C&Q documentation

Job description

Job Purpose

To lead and oversee Engineering, Process Equipment, Utilities, Maintenance, and Projects for a sterile injectable manufacturing facility, ensuring equipment reliability, operational excellence, regulatory compliance, and successful execution of infrastructure development and capacity expansion projects.

Key Responsibilities

• Lead overall Engineering, Process Equipment, Utilities, Maintenance, and Projects operations for the sterile injectable manufacturing facility.
• Ensure optimal performance, reliability, and uptime of process equipment, manufacturing systems, and critical utilities.
• Oversee the installation, commissioning, qualification, validation, and maintenance of process equipment and utility systems.
• Manage preventive, predictive, and breakdown maintenance, including troubleshooting, root cause analysis (RCA), and corrective and preventive actions (CAPA).
• Lead greenfield and brownfield projects, facility development, plant modifications, capacity expansion, and equipment upgradation.
• Review and finalize equipment specifications, URS, plant layouts, PFDs, P&IDs, engineering designs, and project estimates.
• Manage project planning, CAPEX budgeting, cost control, procurement coordination, vendor selection, and execution timelines.
• Coordinate Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), equipment erection, commissioning, and performance verification.
• Ensure compliance with cGMP, WHO-GMP, USFDA, EU-GMP, EHS, and applicable regulatory requirements.
• Maintain engineering documentation, equipment qualification records, calibration records, preventive maintenance schedules, and audit readiness.
• Monitor critical spare inventory, equipment performance, utility consumption, and maintenance expenditure.
• Drive energy conservation, cost optimization, equipment reliability, productivity enhancement, and continuous improvement initiatives.
• Collaborate with QA, Production, Validation, EHS, Procurement, and other stakeholders to ensure smooth execution of engineering and project activities.
• Lead, mentor, and develop the Engineering, Utilities, Maintenance, and Projects teams.

Mandatory Technical Expertise

1. Process Equipment Sterile Injectables

• Aseptic liquid filling lines and vial filling systems.
• Filling line equipment from B+S, Bosch, Groninger, IMA, Tofflon, Optima, Truking, Steriline, or equivalent OEMs.
• Lyophilizers (freeze dryers), autoclaves, and terminal sterilizers.
• Manufacturing vessels, holding vessels, and associated process equipment.
• Equipment selection, technical evaluation, troubleshooting, maintenance, qualification, and performance improvement.

2. Utilities and Facility Systems

• HVAC systems, AHUs, cleanrooms, and environmental control systems.
• Purified Water (PW), Water for Injection (WFI), and clean/pure steam generation and distribution systems.
• Boilers, chillers, air compressors, and other critical plant utilities.
• Building Management System (BMS) and utility monitoring systems.

3. Projects, Qualification and Compliance

• Greenfield sterile injectable facility setup and brownfield expansion projects.
• Equipment erection, installation, commissioning, and qualification, including IQ/OQ/PQ.
• Engineering change control, calibration, preventive maintenance, and GMP documentation.
• Regulatory inspection readiness and engineering compliance.

Candidate Profile

• Bachelors degree in Mechanical Engineering; relevant engineering qualifications preferred.
• 1825+ years of experience in pharmaceutical engineering, with substantial exposure to sterile injectable manufacturing.
• Proven leadership experience in Engineering, Process Equipment, Utilities, Maintenance, and Projects at a senior management level.
• Demonstrated capability in managing sterile facility operations, major engineering projects, CAPEX, and cross-functional teams.
• Strong expertise in process equipment, clean utilities, HVAC systems, project execution, and equipment reliability.
• Sound understanding of aseptic manufacturing practices, cleanroom requirements, GMP compliance, and regulatory expectations.
• Excellent leadership, planning, budgeting, vendor management, and problem-solving skills.

Preferred: Experience in setting up or expanding sterile injectable manufacturing facilities and independently managing end-to-end engineering and project operations.