Director, Sterile Engineering

Job Description

Director Sterile Engineering

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 Companys 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 Divisions 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 Companys 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.

Primary 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

Education Minimum Requirement:

Bachelors degree in Engineering Pharmaceutical Sciences or related scientific field with a minimum of 10 years of relevant experience.

Required Experience and Skills:

• 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

Preferred Experience and Skills:

• 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

Required Skills:

Preferred Skills:

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U.S. Hybrid Work Model

Effective September 5 2023 employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week Monday - Thursday although the specific days may vary by site or organization with Friday designated as a remote-working day unless business critical tasks require an on-site Hybrid work model does not apply to and daily in-person attendance is required for field-based positions; facility-based manufacturing-based or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note this Hybrid work model guidance also does not apply to roles that have been designated as remote.

The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees position within the salary range will be based on several factors including but not limited to relevant education qualifications certifications experience skills geographic location government requirements and business or organizational needs.

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 can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:We will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of applicable state and local laws including the City of Los Angeles Fair Chance Initiative for Hiring Ordinance

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