Associate Specialist, Engineering (Onsite)

MSD•Rahway, NJ

2d•$71,900 - $113,200•Onsite

About The Position

The FLEx Center in Rahway, New Jersey, is a multi-modality drug product development and GMP clinical manufacturing facility. Its FLEx Sterile 2 expansion will add capacity for filling, lyophilization, formulation, sterile supply, and supporting utility suites. The facility is being equipped with robotic isolators and other technologies intended to support flexible, rapid development of clinical drug products. During construction and startup, the selected candidate will contribute relevant experience to equipment and facility design, commissioning and qualification, regulatory certification, and other activities needed to prepare the facility for operations. Once manufacturing begins, the role will partner with formulators, engineers, Quality representatives, and other colleagues to support the quality of clinical supplies and scientifically rigorous processes. Associate Specialist positions are available on the Operations and Technical Operations teams. Technical Operations provides support for formulation and process development, scale-up and technology transfer, manufacturing documentation, facility readiness, equipment operation and troubleshooting, technical assessments, and improvement work. Operations positions provide hands-on sterile manufacturing experience across formulation, component preparation, filling, lyophilization, inspection, and supporting areas. Operations work includes operating and caring for manufacturing systems, maintaining aseptic practices and GMP compliance, completing controlled records, contributing to operational support processes, and coordinating materials and daily floor activities. Candidates must be pursuing an eligible technical degree and preparing to graduate by July 2027, and selected candidates must be available to begin employment by July 2027. The role is based onsite in Rahway, New Jersey, and requires work in Grade C cleanroom conditions with cleanroom gowning and personal protective equipment, including a powered air-purifying respirator. The position is a regular, first-shift role. Domestic relocation is listed; visa sponsorship is not available, and travel requirements are 10%.

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 standard operating procedures and current GxP documents.
Excellent verbal and written communication skills.
Proficiency with Microsoft Office (Word, Excel, and Outlook), equipment human-machine interfaces (HMIs), SAP, and calibration and maintenance database systems.
Ability to lift up to 50 pounds and bend, stoop, squat, crawl, twist, and climb ladders.
Ability to wear required cleanroom protective gowning and personal protective equipment, including respirators and a powered air-purifying respirator, and work in Grade C cleanroom conditions while maintaining appropriate aseptic behaviors.
Ability to 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 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 to support manufacturing.
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 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 manufacturing 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, 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 implementation of process improvements.
Support material movement, staging, inventory checks, line clearance, and coordination of daily floor activities.
Maintain safe work habits and comply with safety and company policies and procedures.