Enzene - Associate Director, Engineering and Operations

About Our Client - Enzene
Enzene Inc. is an emerging Contract Development and Manufacturing Organization (CDMO) with a strong operational footprint in India. We are a subsidiary of Enzene Biosciences, a leading biotechnology company. Our mission is to provide high-quality biologics manufacturing services to our clients, contributing to the advancement of the pharmaceutical industry.

Website: www.enzene.com

Position Overview
The Associate Director, Engineering and Operations will play a crucial leadership role in the completion of the current phase of construction and startup activities of our new manufacturing and laboratory facility, followed by establishing routine preventative maintenance and calibration activities, and coordinating with a third-party integrated facility management provider. Additionally, this position will play a key role in further expansion at the site.

Key Responsibilities

• Lead the strategic planning and execution of startup activities for the new manufacturing and laboratory facility.
• Oversee the setup and management of the Computerized Maintenance Management System (CMMS).
• Develop and implement comprehensive preventative maintenance and calibration programs.
• Establish and maintain strong partnerships with third-party integrated facility management providers to ensure seamless operations.
• Create and enforce standard operating procedures (SOPs) for maintenance and operations, ensuring compliance with all relevant safety and regulatory standards.
• Drive continuous improvement initiatives to optimize facility performance and achieve operational excellence.
• Provide leadership, mentorship, and development opportunities to the engineering and operations teams.
• Collaborate with senior leadership and cross-functional teams, including Manufacturing, Quality Control, Supply Chain, Process Development, and Quality Assurance, to support facility needs and improvements.
• Manage budgets, resources, and timelines effectively to meet operational and strategic goals.
• Play a key role in the further expansion of the site, including planning and executing facility upgrades and expansions.
• Lead interactions with Quality Assurance for procedures, change controls, deviation investigations, and onsite audit support.
• Support validation activities as needed, ensuring compliance with industry standards and best practices.
• Establish, manage, and communicate project budgets and timelines.
• Serve as the primary point of contact for third-party engineering and construction management firms.
• Report to the Director of Facilities and Engineering, providing regular updates on project status, operational performance, and strategic initiatives.

Qualifications

• • Education: Bachelor's degree in Engineering, Operations Management, or a related field or commensurate experience and knowledge gained through industry or military service.
    
• • Experience: Minimum of 10 years of experience in facility management, engineering, or operations, with at least 3 years in a leadership role. Proven experience with CMMS setup and management. Strong knowledge of preventative maintenance and calibration activities.
    
  • Skills: Excellent project management and organizational skills. Ability to work collaboratively with third-party service providers. Strong problem-solving and analytical skills. Excellent communication and interpersonal skills. Ability to work in a fast-paced, dynamic environment.

Why Join Enzene?
At Enzene, we foster a collaborative and innovative environment where science and business intersect. Our team is dedicated to pushing the boundaries of biosimilar manufacturing, and we are constantly striving to improve processes and patient outcomes. Joining Enzene means being part of a company that values integrity, innovation, and collaboration in pursuit of scientific excellence.

We offer an environment of growth, learning, and opportunity in a sector that is driving change in healthcare.

Equal Opportunity Employer
Enzene is an equal opportunity employer, committed to fostering a diverse and inclusive work environment where all employees can thrive.