Director, Sterile Engineering

MSD • Rahway, NJ

8d • Hybrid

About The Position

The Formulation Laboratory and Experimentation (FLEx) Center in Rahway, New Jersey provides a launch pad for the commercial formulation development and GMP clinical supply manufacture of our Company's drug product pipeline. The FLEx Sterile Engineering Lead will steer this facility within the FLEx network. Additionally, the lead will provide engineering support for the Sterile Liquids Pilot Plant (SLP) at the West Point site. The lead will collaborate closely with operations and support groups from research, global engineering (GES) and site support functions (GWES) in the development of formulations in support of sterile products using the talent, capabilities, and facilities of the FLEx Center. They will be responsible for maintaining a compliant, GMP-licensed manufacturing facility with the capability to manufacture supplies for early and late phase clinical trials, in a multi-shift operation. Close partnership with colleagues from Quality, Facilities Management (GWES, EM&U), GES and our Research & Development Division's IT will be required to ensure effective utilization of these facilities in support of clinical development. The Engineering Lead is the steward of these key our Company's assets, ensuring the capabilities and operating model are developed and maintained over time to effectively support a dynamic and complex pipeline. The Lead will sponsor and drive asset reliability and continuous improvement to realize the vision of the FLEx Center, founded on more inclusive collaboration in a workforce of great diversity, to enable the promise of the pipeline and more fully develop our talent. They will help to create an entrepreneurial culture which values diversity in all its forms as a catalyst to innovation and engineering, recognizes the freedom to experiment, is a safe environment to challenge, nurtures a keen sense of belonging, and motivates all to achieve their potential. Critically, the Lead will drive a culture of perpetual adherence to engineering, safety and compliance standards. A successful candidate should have relevant sterile Drug Product GMP facility engineering and/or operations experience, an affinity for hands-on problem solving, and excellent leadership and communication skills. The role is based in New Jersey (primary) and Pennsylvania (secondary) and reports to the Senior Director of Engineering in Pharmaceutical Operations & Clinical Supply.

Requirements

• Bachelor's degree in Engineering, Pharmaceutical Sciences or related scientific field with a minimum of 10 years of relevant experience.
• Knowledge of and experience supporting sterile Drug Product manufacturing, including the use of advanced product filling and formulation equipment, application of isolators and advanced robotics
• Sterile engineering experience in a GMP clinical or commercial manufacturing environment
• Effective interpersonal and communication skills, both verbal and written
• Excellent organizational skills to manage multiple priorities
• History of independent problem-solving
• Experience with leading complex teams / matrix management
• Accountability
• Accountability
• Allen Bradley PLC
• Analytical Thinking
• Capital Projects
• Clinical Development
• Clinical Manufacturing
• Clinical Trials
• Cost Management
• Driving Continuous Improvement
• Employee Development
• Global Engineering
• GMP Compliance
• Good Manufacturing Practices (GMP)
• Innovation
• Leadership
• Maintenance Processes
• Maintenance Supervision
• Manufacturing Equipment
• People Leadership
• Pharmaceutical Process Development
• Programmable Logic Controller (PLC)
• Project Management
• Regulatory Compliance
• Resource Management

Nice To Haves

• Experience with GMP facility engineering, including utilities and infrastructure
• Experience with leading organizational change
• Experience in leading and supporting quality investigations and change management
• Experience with a GMP Quality Management System (QMS)
• Familiarity with US and EU GMP and Safety compliance regulations
• Experience with CMMS & CCMS systems and Reliability Based Engineering methodology
• Familiarity with computer systems and applications including but not limited to: Programmable Logic Controllers (PLCs), Calibration/Maintenance Database Systems

Responsibilities

• Oversee facility start-up /readiness for FLEx2 (GES capital project) and the daily operation of FLEx1 (facility in operation). This includes equipment engineering, automation, bio-sterile validation, maintenance & calibration, safety and compliance requirements to support development or GMP activities
• Oversee engineering activity and support for the Sterile Liquids Pilot Plant (WP17 SLP)
• Manage, develop, and grow a team of facility-facing engineers
• Provide trouble-shooting support on the shop floor
• Support internal capability development by evaluating and deploying innovative sterile manufacturing technologies to support new product development, both automated and non-automated
• Collaborate effectively within and across functional areas and possess advanced knowledge or experience in specialized engineering areas. The desired individual is someone who will bring deep subject matter expertise to the position as well as have the discipline to drive results.
• Maintain awareness of relevant new and current sterile Drug Product manufacturing technologies, capabilities, and effectively share this knowledge with others.
• Develop and lead Commissioning, Qualification & Validation activities (CQV)
• Participate in external and internal audits, tours, and inspections
• Ensure closure of investigations, as needed
• Establish and manage expense and capital projects, including expenditures via financial budgets and forecasts associated with the FLEx Center and the SLP
• Maintain facility and equipment systems in a state of permanent inspection readiness
• Recruit and develop staff, through objective setting, rewards and recognition, stretch leadership and/or technical assignments, and learning opportunities that broaden experience
• Sponsor and drive a culture of continuous improvement across these facilities

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director