Associate Specialist, Engineering (Onsite)

Merck•Rahway, NJ

8d•$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 sterile clinical manufacturing capacity, including 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 and clinical supply manufacturing. During construction and startup, the selected candidate will contribute to equipment and facility design, system commissioning and qualification, regulatory certification, and other activities supporting operational readiness. Once operations begin, the role will partner 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 in the Operations and Technical Operations teams. Technical Operations work includes providing technical support for formulation, process development, scale-up, and technology transfer; supporting manufacturing documentation and investigations; contributing to commissioning, qualification, and regulatory readiness; troubleshooting aseptic manufacturing equipment; and supporting technical assessments and improvements. Operations work provides hands-on sterile manufacturing experience across formulation, component preparation, filling, lyophilization, inspection, and related support areas, with responsibilities for equipment operation, aseptic practices, GMP documentation, operations support, material movement, and daily floor coordination. Candidates must be pursuing an eligible technical degree and preparing to graduate by July 2027. Selected candidates must be available to start employment by July 2027. The role is based onsite in Rahway, New Jersey, and requires work in Grade C cleanroom conditions, wearing required gowning and PPE, including a powered air-purifying respirator. The position is a regular, day-shift role; 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.
Must be willing and able to lift up to 50 pounds; bend, stoop, squat, crawl, twist, and climb ladders.
Ability to wear required cleanroom protective gowning and PPE, 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 within sterile drug product operations, formulation, filling, lyophilization, inspection, or equipment operation.

Responsibilities

For Technical Operations: Provide technical support for formulation, process development, scale-up, and technology transfer activities.
For Technical Operations: Draft and maintain investigations, change controls, standard operating procedures, batch documentation, and technical protocols.
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 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.
For Operations: 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.
Maintain safe work habits and comply with safety and company policies and procedures.