Associate Specialist, Engineering

About the Role

The Formulation, Laboratory, and Experimentation (FLEx) Center in Rahway, New Jersey, is a new multi-modality (small molecule, biologics, vaccine) Drug Product development and Good Manufacturing Practice (GMP) clinical manufacturing plant. FLEx Sterile 2 is a strategic expansion to increase sterile clinical manufacturing capacity. The facility will be equipped with leading-edge robotic isolators and novel technologies to enable speed and flexibility in drug product development. As the facility is under construction, the selected candidate will contribute to equipment and facility design, system commissioning/qualification, regulatory certification, and other critical activities for facility startup and operational readiness. Upon commencement of operations, the individual will partner with formulators, engineers, Quality representatives, and other team members to ensure the quality of clinical supplies, the scientific rigor of processes, and to enable flexibility and speed of the sterile pipeline.

Key Responsibilities

Technical Operations (FLEx Tech Ops)

• Provide technical support for formulation, process development, scale-up, and technology transfer activities.
• Support manufacturing by drafting and maintaining investigations, change controls, standard operating procedures, batch documentation, and technical protocols.
• Support commissioning, qualification, and regulatory readiness activities for the FLEx Sterile clinical manufacturing facility.
• Support operation and troubleshooting of aseptic formulation, filling, and lyophilization equipment across the manufacturing lifecycle.
• Manage assigned technical work and contribute to facility, equipment, and process improvements.
• Assist with data review, technical assessments, troubleshooting, and continuous improvement activities.

Operations (FLEx Operations)

• Build foundational, hands-on sterile manufacturing floor experience by executing sterile operations in formulation, component preparation, filling, lyophilization, inspection, and associated support areas in accordance with approved procedures.
• Develop practical equipment knowledge by preparing, operating, monitoring, cleaning, and supporting troubleshooting of manufacturing systems while maintaining aseptic practices and GMP compliance.
• Gain experience with GMP operations support by completing electronic and paper batch records, logbooks, checklists, standard operating procedures, and other controlled documentation accurately and in real time.
• Build operations-support experience by contributing to deviation investigations, corrective and preventive actions, change controls, SOP development and revision, and implementation of process improvements.
• Develop an end-to-end understanding of manufacturing operations through material movement, staging, inventory checks, line clearance, and coordination of daily floor activities.

Requirements & Tech Stack

• GMP principles and safety requirements.
• Strong problem-solving and organizational skills.
• Ability to work independently and manage multiple priorities and deadlines.
• Ability to communicate and work in partnership with other employees in a manufacturing environment.
• Ability to prepare Standard Operating Procedures and current GXP documents.
• Excellent verbal and written communication skills.
• Proficiency with computer systems and applications, including Microsoft Office (Word, Excel, and Outlook), equipment human-machine interfaces (HMIs), SAP, and calibration and maintenance database systems.
• Willing and able to lift up to 50 pounds; bend, stoop, squat, crawl, twist, and climb ladders.
• Ability to wear required cleanroom protective gowning, including respirators.
• Ability to complete all required gowning, wear required personal protective equipment, including a powered air-purifying respirator, and work in Grade C cleanroom conditions while consistently maintaining appropriate aseptic behaviors.
• Demonstrate safe work habits and maintain a safe work environment. Comprehend and comply with all safety and company policies and procedures.

Qualifications

• Bachelor’s degree in an engineering discipline (including mechanical, chemical, biochemical, biomedical, electrical, industrial, or related engineering), chemistry, biological sciences, pharmaceutical sciences, or another related technical discipline.
• Candidates must be currently pursuing an eligible degree and preparing to graduate by July 2027.
• Individuals selected will need to be available to start their employment by July 2027.

Preferred Experience And Skills

• Internship, co-op, laboratory, pilot plant, or manufacturing experience in the pharmaceutical, biotechnology, or similarly regulated industry.
• Hands-on experience gained through academic or personal projects, machine-shop work, construction, equipment assembly, maintenance, fabrication, repair, or similar practical activities.
• Experience working effectively in a cross-functional team.
• Exposure to change control, deviation management, root cause analysis, or corrective and preventive action processes.
• Technical writing or controlled-document experience.
• Experience operating, setting up, disassembling, and adjusting complex equipment within sterile drug product operations, formulation, filling, lyophilization, inspection, or equipment operation.