Associate Director, Facility & Utilities Engineering Lead

Merck • Rahway, NJ

2d • Hybrid

About The Position

The Biologics Process Research & Development organization within our Company Research Labs is responsible for developing the drug substance manufacturing processes for our Company's biologics pipeline. We work closely with colleagues in Discovery, Pre-clinical, and Early Development to rapidly develop processes for diverse biotherapeutics and efficiently produce material to supply clinical trials. We are also responsible for commercial process development, and development and implementation of new technologies. We work with our partners in our Company Manufacturing Division to commercialize and launch new products. This role will support the Next Generation Biologics (NGB) facility, which will be a premier, state-of-the-art facility, that is a key part of our Chemistry, Manufacturing, and Controls (CMC) hub at our site headquarters in Rahway, NJ. This facility will be fully online in the next few years, both in terms of facility construction and organizational realization. The GMP facility is designed for multi-product operations with flexible operating suites, which can adjust as the clinical pipeline demands change. It can meet all historic, currently existing, and cutting-edge biologics program demands from supporting development to pilot, small- and large-scale potent material handling, and the ability to integrate new technologies and cell-line platforms. The Facility & Utilities Engineering Lead will be a member of the Engineering & Automation leadership team and will report to the Head of Engineering & Automation for NGB.

Requirements

• Bachelor’s degree in chemical/biochemical engineering, pharmaceutical sciences, chemistry, biochemistry, biology, microbiology, or related discipline with minimum of 8 years relevant experience, or a Master’s degree with minimum 6 years of relevant experience.
• Demonstrated experience (8 years minimum) in a GMP-regulated biological drug substance manufacturing environment, ideally with experience of single-use systems.
• Prior experience of team management and monitoring performance
• Possess a deep understanding of a facilities and engineering management in GMP (Good Manufacturing Practice) environment with detailed knowledge and experience of clean utilities systems.
• Strong working knowledge of cGMP, Quality Systems (problem, deviations, change management, etc.), Safety for operations.
• Ability to perform technical analysis to drive continuous improvement and overall efficiency.
• Ability to lift 25 lbs, if required.

Nice To Haves

• Culture Building: Establish a high-performance culture that promotes innovation, diversity, and inclusion within the team
• Track record of working effectively with team-members of diverse skill sets and backgrounds
• Excellent troubleshooting and problem-solving skills and the ability to overcome technical and organizational challenges
• Delta V and MES (Manufacturing Execution System) knowledge and experience
• Strong verbal and written communication skills, and attention to detail
• Experienced in the administration of GMPs, Good Documentation Practices (GDPs), and S&E regulations as it pertains to engineering.
• Proven self-motivation, ability to drive improvements, and inspire others.
• Demonstrated ability to work effectively as part of diverse teams.
• Ability to challenge the status quo with a continuous improvement mindset.
• Strong leadership ability and collaborative skills.
• Strong analytical and presentation skills.

Responsibilities

• Lead the Facility & Utilities Engineering team to ensure 24/7/ 365 building support for critical GMP operations.
• Manage process & facilities equipment, and utilities (clean and grey) maintenance and calibration.
• Maintain redundancy through training for operation, metrology, maintenance, etc. to provide off-hours, weekends and holidays coverage.
• Ensure areas of accountability are delivered in accordance with EHS regulatory and company EHS requirements.
• Build robust communication channels with site support teams (utilities, etc.) and NGB operations to coordinate planned and unplanned activities, annual shutdowns to maintain robust building operations.
• Manage and provide oversight to outsource service providers, such as equipment service providers, GMP area cleaning, etc.
• Drive continuous improvement programme across all areas – safety, environmental management, quality compliance, equipment reliability and uptime, efficiency and operational excellence.
• Manage a team, which includes hiring and building team capabilities and performance management to meet the operational requirements of the facility as well as provide leadership and personnel development strategies.
• Support facility and utilities assessment for New Product Introduction, as required.
• Support Energy Management, Environmental Sustainability & Business Continuity activities through data.
• Accountable for delivery of Engineering spend within approved budget.
• Investigate equipment failures or area deviations to find root cause and implement effective Corrective and Preventative Actions (CAPA).
• Conduct life cycle analysis of all critical system equipment to ensure equipment is upgraded and replaced in accordance with the Site Master Plan.
• Serve as a technical mentor and help train rotational and new employees, and supervise staff performing GMP activities and deliver training as needed.

Benefits

• The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
• We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days.
• More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees