General Manager Engineering (Sterile facility)

Immacule Life Sciences; Solan; On-site; INR 1,800,000 - 2,800,000; Full time

Job summary

Immacule Life Sciences is seeking a seasoned engineering leader to head Engineering, Utilities, Maintenance and Projects in a sterile injectable manufacturing facility. You will ensure reliability of process equipment, regulatory compliance and continuous improvement across utilities and manufacturing lines.

You will manage preventive, predictive and breakdown maintenance, lead installation and qualification activities, and drive Greenfield/Brownfield projects while coordinating with

Qualifications

• B.E./B.Tech in Mechanical, Electrical or Instrumentation or related discipline.
• 1825+ years of pharmaceutical engineering experience with exposure to USFDA/EU GMP-approved sterile injectable facilities.

Responsibilities

• Lead Engineering, Utilities, Maintenance, and Projects to ensure uptime.
• Ensure maximum uptime of process equipment and utilities.
• Manage preventive, predictive, and breakdown maintenance.
• Lead equipment installation, commissioning, qualification, validation, and calibration.
• Execute Greenfield/Brownfield projects, plant modifications, and capacity expansion.
• Review plant layouts, PFDs, P&IDs, engineering designs, and project estimates.
• Manage project planning, budgeting, procurement, vendor development, and execution.
• Ensure compliance with cGMP, WHO, USFDA, EU GMP, EHS, and Data Integrity.
• Support regulatory audits and engineering documentation.
• Drive cost optimization, energy conservation, reliability, and productivity improvements.
• Lead and develop the Engineering team while providing cross-functional support.

Skills

Sterile injectable manufacturing

Aseptic practices

GMP documentation

Engineering compliance

RCA & CAPA

Education

BE/B.Tech in Mechanical/Electrical/Instrumentation or related discipline

Job description

Purpose

Lead Engineering, Utilities, Maintenance, and Projects to ensure reliable plant operations, regulatory compliance, and continuous improvement in a sterile injectable manufacturing facility.

Key Responsibilities

• Lead Engineering, Utilities, Maintenance, and Projects.
• Ensure maximum uptime of process equipment and utilities.
• Manage preventive, predictive, and breakdown maintenance.
• Handle equipment breakdowns through RCA and CAPA.
• Lead equipment installation, commissioning, qualification, validation, and calibration.
• Execute Greenfield/Brownfield projects, plant modifications, and capacity expansion.
• Review plant layouts, PFDs, P&IDs, engineering designs, and project estimates.
• Manage project planning, budgeting, procurement, vendor development, and execution.
• Ensure compliance with cGMP, WHO, USFDA, EU GMP, EHS, and Data Integrity requirements.
• Support regulatory audits and engineering documentation.
• Monitor critical spare inventory and utility performance.
• Drive cost optimization, energy conservation, reliability, and productivity improvements.
• Lead and develop the Engineering team while providing cross-functional support.

Technical Requirements

• Strong experience in sterile injectable manufacturing.
• Sound knowledge of aseptic practices, cleanroom behavior, GMP documentation, and engineering compliance.
• Ability to independently manage engineering operations and projects in a regulated pharmaceutical environment.

Mandatory Equipment Exposure

• Filling Lines (B+S, Bosch, Groninger, IMA, Tofflon, Optima, Truking, Steriline, etc.)
• Lyophilizers
• Autoclaves
• Manufacturing & Holding Vessels
• HVAC, PW/WFI Systems, Clean Steam
• Boilers, Chillers, Air Compressors, BMS and other plant utilities.

Qualification & Experience

• B.E./B.Tech (Mechanical/Electrical/Instrumentation or related discipline).
• 1825+ years of pharmaceutical engineering experience with significant exposure to USFDA/EU GMP-approved sterile injectable facilities.