Associate Specialist, Engineering (Onsite)

Job Description

Job Description:

The Formulation, Laboratory, and Experimentation (FLEx) Center in Rahway, New Jersey, features a cutting-edge sterile drug product cGMP clinical supply manufacturing facility, known as FLEx Sterile, which is currently in the operational startup phase. The FLEx Sterile facility is poised to play a pivotal role in the long-term success of delivering our clinical pipeline to patients worldwide, encompassing a diverse range of product modalities, including sterile small molecules, biologics, vaccines, and antibody-drug conjugates (ADCs).

We are seeking an Associate Engineer, Technical Operations – Engineering, to serve as a key operations specialist in the FLEx Sterile Expansion Project, which is nearing the completion of its Detailed Design Phase in the capital project. This expansion project aims to more than double the capacity of the existing FLEx Sterile Facility by adding a second clinical filling/lyophilization suite, a formulation suite, and a sterile supply suite, along with various supporting infrastructure and utilities.

As construction and commissioning and qualification of the expansion project commences, the selected candidate will contribute to equipment and facility design, system commissioning and qualification, and other critical activities necessary for facility startup and operational readiness. This role presents an exciting opportunity to collaborate with our research formulation scientists, capital design engineers, safety and quality representatives, digital and IT teams, equipment vendors, and other stakeholders. Together, you will drive the design aspects, conduct risk assessments, engage in strategic planning, and ensure the successful execution of the project C&Q and startup phases.

When operations commence, this individual will partner closely with the formulators, engineers, Quality representatives, and other team members to ensure the quality of the clinical supplies, the scientific rigor of the processes, and ultimately to enable flexibility and speed of our Company's sterile pipeline.

Key Responsibilities

• Collaborate closely with a diverse range of stakeholders to gain insights into equipment and facility design, maintenance, troubleshooting, operational excellence, financial and capital management, team building, process sciences, technical writing, and networking.

• Work with a variety of state-of-the-art aseptic drug product formulation, filling, and lyophilization equipment while completing processes throughout the manufacturing cycle

• Support individual project assignments and aid in facility and process equipment innovation.

• Perform manual and/or automated operations, general maintenance, troubleshooting and support functions

• Perform aseptic manipulations within Grade A barrier isolation systems

• Contemporaneous record keeping including equipment and area cleaning and use logs, and all pertinent batch and/or equipment preparation documentation.

• Identify and addresses compliance, environmental, safety, and process deviations as appropriate while notifying appropriate personnel

• Demonstrate, at all times, safe work habits and maintain a safe work environment. Comprehend and comply with all safety and company policies and procedures.

• Attend training classes, workshops, meetings, etc., as needed to improve job skills and product-related procedures.

Education Minimum: 

• B.A./B.S. in Mechatronics, Engineering, Automated Sciences, Computer Science, Biology, Chemistry or equivalent by May 2026

Qualifications:

• Ability to do all required gowning and personal protective equipment ex. Powered Air Purifying Respirator.

• Strong attention to detail and documentation skills are required

• Ability to communicate and work in partnership with other employees in a manufacturing environment

• Ability to prepare Standard Operating Procedures and current GXP documents.

• Demonstrated skills in problem-solving and troubleshooting.

• Effective communication skills, both ve