Associate Specialist, Engineering - 2nd Shift (Onsite)

Job Description

Job Description:

The Formulation, Laboratory, and Experimentation Center is a new multi-modality (small molecule, biologics, vaccine) Drug Product development and Good Manufacturing Practice clinical manufacturing plant in Rahway, New Jersey. Formulation, Laboratory, and Experimentation Sterile 2 is a strategic expansion that will increase sterile clinical manufacturing capacity through additional filling, lyophilization, formulation, sterile supply, and supporting utility suites.

To enable our Company’s ever evolving pipeline the new Formulation, Laboratory, and Experimentation Sterile 2 facility will be equipped with leading edge robotic isolators and novel technologies. These technologies will enable speed and flexibility driving drug products from concepts to clinical supplies for our patients. As the facility is currently under construction, the selected candidate will apply her/his relevant experience to contribute to equipment and facility design, system commissioning/qualification, regulatory certification, as well as other workstreams’ critical activities to enable facility startup and operational readiness.

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.

Technical Operations:

• 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 Formulation, Laboratory, and Experimentation 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:

• 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 Good Manufacturing Practice compliance.

• Gain experience with Good Manufacturing Practice 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 deviation investigations, corrective and preventive actions, change controls, SOP development and revision, and implementation of process improvements.

• Develop end-to-end understanding of manufacturing operations through material movement, staging, inventory checks, line clearance and coordination of daily floor activities.

Education Minimum Requirements:

• 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

Required Experience and Skills:

• Knowledge of Good Manufacturing Practice principles and safety requirements, with the ability to learn and apply site procedures and regulatory expectations.

• Strong problem-solving and organizational skills, with the 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.
• Must be willing and able to lift up to 50 pounds; bend, stoop, squat, crawl, twist, and climb ladders; and 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.

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