Senior Specialist, Engineering

Job Description

The Formulation, Laboratory, and Experimentation (FLEx) Center located in Rahway, New Jersey includes a state-of-the-art sterile drug product cGMP clinical supply manufacturing facility known as FLEx Sterile that is currently in operational startup phase. The FLEx Sterile facility will play a major role in the long-term success of delivering our clinical pipeline to patients across the globe throughout a range of product modalities which includes sterile small molecule, biologics, vaccines, antibody drug conjugates (ADCs), in addition to others.    

The Senior Specialist, Engineering will serve as a business representative in the FLEx Sterile Expansion Project which is currently in Conceptual Design Phase (also known as Front End Loading Phase II, FEL-2). The FLEx Sterile Expansion Project is intended to more than double the expected capacity of the existing FLEx Sterile Facility by way of bringing on a second clinical filling/lyophilization suite, formulation suite, as well as sterile supply suite in addition to various supporting infrastructure and utilities.

This is an exciting opportunity to partner with our Company's Research Laboratories (M formulation scientists, Global Engineering Solutions (GES) engineers, Safety and Quality representatives, Digital and IT, equipment vendors, and other team members to drive the design aspects, risk assessments, strategic planning, execution, facility startup and operational readiness of the FLEx Sterile Expansion Project. This individual will collaborate closely across a wide range of stakeholders and gain depth and breadth from a multitude of topics spanning equipment and facility design, financial and capital management, team building, process sciences, operational excellence, technical writing, and networking. 

The role is based in at our Corporate Headquarters in Rahway, New Jersey and reports to the FLEx Sterile Expansion Business Lead within Pharmaceutical Operations and Clinical Supply. 

Education Minimum Requirements: 

• Bachelor’s degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with a minimum of 4 years relevant experience

• Master’s degree with a minimum of 2 years relevant experience

Required Experience and Skills:

• Familiarity with United States and European Union cGMP and Safety compliance regulations.

• Ability to prepare Risk Assessments, Standard Operating Procedures (SOP) and current GXP documents.

• Effective interpersonal and communication skills, both verbal and written.

• Excellent organizational skills to multi-task.

• Desire and willingness to learn, contribute and lead.

• Experience in drug product aseptic processing, equipment and aseptic technique.

• Track-record of independent problem-solving.

Preferred Experience and Skills:

• Ability to convert new drug product attributes and process needs to an executable series of steps and …