Associate Specialist, Engineering - 2nd Shift (Onsite)

Merck•Rahway, NJ

7d•$71,900 - $113,200•Onsite

About The Position

The Associate Specialist, Engineering will support development and startup of the Formulation, Laboratory, and Experimentation Sterile 2 clinical manufacturing facility in Rahway, New Jersey. The facility is a multi-modality drug product development and Good Manufacturing Practice (GMP) clinical manufacturing plant, expanding sterile clinical manufacturing capacity through filling, lyophilization, formulation, sterile supply, and supporting utility suites. While the facility is under construction, the role contributes relevant experience to equipment and facility design, system commissioning and qualification, regulatory certification, and other activities needed for startup and operational readiness. Once operations commence, the individual will work closely with formulators, engineers, Quality representatives, and other colleagues to support clinical supply quality, scientific rigor, and the flexibility and speed of the sterile pipeline. The position provides technical support for formulation, process development, scale-up, technology transfer, manufacturing documentation, equipment troubleshooting, and continuous improvement. It also builds hands-on sterile manufacturing experience across formulation, component preparation, filling, lyophilization, inspection, and support areas. The employee will operate and support manufacturing systems while maintaining aseptic practices and GMP compliance, and will contribute to facility and process readiness and improvement. This is an onsite, second-shift evening role. Candidates must be pursuing an eligible technical degree and preparing to graduate by July 2027, and must be available to start employment by July 2027. The role requires work in Grade C cleanroom conditions, required protective gowning including a powered air-purifying respirator, and physical activities including lifting up to 50 pounds and bending, stooping, squatting, crawling, twisting, and climbing ladders. The posted base salary range for the primary location is $71,900 to $113,200, and the successful candidate will be eligible for an annual bonus and long-term incentive, if applicable.

Requirements

Currently pursuing an eligible degree and preparing to graduate by July 2027; must be available to start employment by July 2027.
Bachelor’s degree in an engineering discipline (including mechanical, chemical, biochemical, biomedical, electrical, industrial, or related engineering), chemistry, biological sciences, pharmaceutical sciences, or another related technical discipline.
Knowledge of Good Manufacturing Practice 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.
Willingness and ability 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 personal protective equipment 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, while complying 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 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 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, 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 process improvement implementation.
Support manufacturing operations through 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.