Associate Specialist, Engineering - 2nd Shift (Onsite)

MSD • Rahway, NJ

2d • $71,900 - $113,200 • Onsite

About The Position

The Formulation, Laboratory, and Experimentation (FLEx) Center in Rahway, New Jersey, is a multi-modality drug product development and GMP clinical manufacturing facility. FLEx Sterile 2 is a strategic expansion intended to increase sterile clinical manufacturing capacity through additional filling, lyophilization, formulation, sterile supply, and supporting utility suites. The new facility will use robotic isolators and other advanced technologies to support the development of drug products and clinical supplies.

While the facility is under construction, the selected candidate will contribute relevant experience to equipment and facility design, system commissioning and qualification, regulatory certification, and other activities supporting facility startup and operational readiness. Once operations begin, the individual will work with formulators, engineers, Quality representatives, and other colleagues to support clinical-supply quality, scientific rigor, and a flexible, responsive sterile pipeline.

The role combines technical operations support with hands-on sterile manufacturing. It supports formulation and process development, scale-up, technology transfer, documentation, equipment operation and troubleshooting, and facility and process improvements. It also provides practical experience in sterile operations, GMP documentation, equipment systems, and day-to-day manufacturing support. The position is onsite in Rahway, New Jersey, on the second (evening) shift. Candidates must be pursuing an eligible degree, expect to graduate by July 2027, and be available to start employment by July 2027.

Requirements

• Bachelor’s degree in an engineering discipline, 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.
• 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 SOPs and current GxP documents.
• Excellent verbal and written communication skills.
• Proficiency with computer systems and applications, including Microsoft Office (Word, Excel, and Outlook), equipment 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 required gowning, wear required PPE 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 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 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.

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

Benefits

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

What This Job Offers

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