General Manager Engineering - Sterile Injectable Facility

About Immacule Life Sciences

Established in 2012, Immacule Life Sciences has earned a distinguished reputation in the pharmaceutical sector. With a strong team of scientists and expansive capabilities, the company delivers customized end-to-end pharmaceutical services focused on liquid and lyophilized injectables. Immacule integrates research, development, and commercialization, specializing in sterile injectable products with robust terminal sterilization and aseptic filling processes. The firm is a recognized CDMO advancing in the competitive sterile US market, holding numerous ANDA approvals and aiming for over fifty submissions by 2025. Quality certifications include USFDA, EU-GMP Hungary, TGA Australia, and Health Canada.

Role Purpose and Key Responsibilities

• Oversee Engineering, Utilities, Maintenance, and Project teams ensuring consistent plant operations and regulatory adherence within a sterile injectable manufacturing environment.
• Maximize uptime of production machinery and essential utilities through rigorous preventive, predictive, and breakdown maintenance systems.
• Conduct root cause analyses and corrective action planning to address equipment failures efficiently.
• Manage installation, commissioning, validation, and calibration activities of new and existing equipment.
• Lead greenfield and brownfield projects, including facility modifications and capacity expansions.
• Evaluate and approve plant layouts, process flow diagrams, piping & instrumentation diagrams, and engineering design calculations along with project budgets and procurement strategies.
• Ensure strict compliance with cGMP, WHO, USFDA, EU GMP, Environmental Health & Safety standards, and data integrity protocols.
• Support audits through thorough preparation and maintenance of engineering documentation.
• Maintain optimal inventory of critical spares and monitor utility system performances.
• Pursue cost optimization, energy conservation, and continuous improvements to equipment reliability and productivity.
• Lead development and performance management of the engineering team while collaborating across departments.

Technical and Equipment Expertise

• Extensive experience with sterile injectable production processes and aseptic manufacturing protocols, including cleanroom operations and GMP compliance.
• Proficient in handling high-tech filling lines including brands such as B+S, Bosch, Groninger, IMA, Tofflon, Optima, Truking, and Steriline.
• Deep knowledge of lyophilizers, autoclaves, manufacturing and holding vessels, HVAC systems, PW/WFI systems, clean steam, boilers, chillers, air compressors, and building management systems.
• Ability to independently manage engineering operations and complex pharmaceutical projects in tightly regulated environments.

Qualifications and Experience

• Bachelor's degree in Engineering (Mechanical, Electrical, Instrumentation, or related discipline).
• 18 to 25 years of experience in pharmaceutical engineering, notably within USFDA and EU GMP approved sterile injectable manufacturing facilities.