Associate Specialist, Engineering (Onsite)

MSD•Rahway, NJ

20h•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 plant. FLEx Sterile 2 is a strategic expansion of sterile clinical manufacturing capacity, adding filling, lyophilization, formulation, sterile supply, and supporting utility suites. The facility is being equipped with robotic isolators and other technologies intended to support flexible, efficient development of clinical drug products. Because 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 candidate will work with formulators, engineers, Quality representatives, and other colleagues to support the quality and scientific rigor of clinical supplies and the sterile pipeline. Associate Specialist positions are available on the Operations and Technical Operations teams. Technical Operations work includes technical support for formulation and process development, scale-up, technology transfer, manufacturing documentation, facility readiness, equipment troubleshooting, and continuous improvement. Operations work provides hands-on sterile manufacturing experience in formulation, component preparation, filling, lyophilization, inspection, and related support areas, while following approved procedures, aseptic practices, and GMP requirements. Candidates must be pursuing an eligible degree and preparing to graduate by July 2027, and must be available to start employment by July 2027. The role is based primarily in Rahway, New Jersey, is a first-shift position, and requires work in Grade C cleanroom conditions with required gowning and personal protective equipment. Travel requirements are 10%.

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 Microsoft Office applications, including Word, Excel, and Outlook; equipment human-machine interfaces (HMIs); SAP; and calibration and maintenance database systems.
Ability and willingness to lift up to 50 pounds and bend, stoop, squat, crawl, twist, and climb ladders.
Ability to wear required cleanroom protective gowning and respirators, complete required gowning, and use required personal protective equipment, including a powered air-purifying respirator.
Ability to work in Grade C cleanroom conditions while consistently maintaining appropriate aseptic behaviors.
Ability to demonstrate safe work habits 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.
Draft and maintain investigations, change controls, standard operating procedures, batch documentation, and technical protocols.
Support commissioning, qualification, and regulatory readiness for the FLEx Sterile clinical manufacturing facility.
Operate and troubleshoot 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.
Execute sterile manufacturing operations in formulation, component preparation, filling, lyophilization, inspection, and associated support areas according to approved procedures.
Prepare, operate, monitor, and clean manufacturing systems, support troubleshooting, and maintain 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.
Follow safety and company policies and procedures and maintain a safe work environment.