Associate Specialist, Engineering - 2nd Shift (Onsite)

MSD • Rahway, NJ

18h • Onsite

About The Position

The Formulation, Laboratory, and Experimentation Center in Rahway, New Jersey is a multi-modality drug product development and Good Manufacturing Practice (GMP) clinical manufacturing plant. Its Sterile 2 expansion will add filling, lyophilization, formulation, sterile supply, and supporting utility suites, using robotic isolators and other technologies to support clinical drug product development and manufacturing.

While the facility is under construction, the selected candidate will contribute to equipment and facility design, system commissioning and qualification, regulatory certification, and other activities needed for startup and operational readiness. Once operations begin, the Associate Specialist will work with formulators, engineers, Quality representatives, and other team members to support clinical supplies and sterile manufacturing processes.

The role combines technical operations support with hands-on sterile manufacturing floor work. It supports formulation, process development, scale-up, technology transfer, equipment operation and troubleshooting, controlled documentation, and continuous improvement. The position requires adherence to aseptic practices, GMP requirements, safety procedures, and cleanroom requirements.

Requirements

• Bachelor’s degree in an engineering discipline, chemistry, biological sciences, pharmaceutical sciences, or another related technical discipline.
• Must be currently pursuing an eligible degree and preparing to graduate by July 2027.
• Must be available to start employment by July 2027.
• Knowledge of GMP principles and safety requirements, with the ability to learn and apply site procedures and regulatory expectations.
• Strong problem-solving and organizational skills, including 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 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 and bend, stoop, squat, crawl, twist, and climb ladders.
• Ability to wear required cleanroom protective gowning, including respirators, and work in Grade C cleanroom conditions while maintaining aseptic behaviors.
• Ability to complete required gowning and wear required personal protective equipment, including a powered air-purifying respirator.
• Demonstrate safe work habits and maintain a safe work environment at all times.
• Comprehend and comply with all safety and company policies and procedures.

Nice To Haves

• Internship, co-op, laboratory, pilot plant, or manufacturing experience in the pharmaceutical, biotechnology, or a similarly regulated industry.
• Hands-on experience from 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 in sterile drug product operations, formulation, filling, lyophilization, inspection, or equipment operation.

Responsibilities

• 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 sterile clinical manufacturing facility.
• Support operation and troubleshooting of aseptic formulation, filling, and lyophilization equipment throughout 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.
• Execute sterile operations in formulation, component preparation, filling, lyophilization, inspection, and associated support areas in accordance with approved procedures.
• Prepare, operate, monitor, clean, and support troubleshooting of manufacturing systems while maintaining aseptic practices and GMP compliance.
• Complete electronic and paper batch records, logbooks, checklists, standard operating procedures, and other controlled documentation accurately and in real time.
• Contribute to deviation investigations, corrective and preventive actions, change controls, SOP development and revision, and process improvements.
• Support material movement, staging, inventory checks, line clearance, and coordination of daily floor activities.

Benefits

• Medical, dental, and vision healthcare and other insurance benefits for employees and family.
• Retirement benefits, including a 401(k).
• Paid holidays, vacation, compassionate days, and sick days.
• Eligible for an annual bonus and long-term incentive, if applicable.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level