Associate Specialist, Engineering (Onsite)

Merck & Co.; Rahway (NJ); On-site; USD 72,000 - 113,000; Full time

Job summary

Merck & Co. in Rahway, NJ, invites applications for a technically focused role in the FLEx Tech Ops/Operations teams. You will support formulation, filling, lyophilization, and aseptic processes, while contributing to qualification, commissioning, and regulatory readiness activities.

A Bachelor's in an engineering or related technical field with GMP exposure is expected, with July 2027 graduation targeted. You will work closely with formulators, engineers, and QA to ensure product quality,

Qualifications

• Knowledge of GMP principles and safety requirements.
• Strong problem-solving and organizational skills.
• Ability to communicate and work with others in a manufacturing environment.
• Ability to prepare SOPs and current GXP documents.
• Excellent verbal and written communication skills.
• Proficiency with Microsoft Office, HMIs, SAP, and calibration databases.

Responsibilities

• Provide technical support for formulation, process development, scale-up, and technology transfer activities.
• Draft and maintain investigations, change controls, SOPs, batch documentation, and technical protocols.
• Support commissioning, qualification, and regulatory readiness activities for the FLEx Sterile facility.
• Support operation and troubleshooting of aseptic formulation, filling, and lyophilization equipment.
• Manage assigned technical work and contribute to facility, equipment, and process improvements.
• Assist with data review, technical assessments, troubleshooting, and continuous improvement.

Skills

GMP knowledge

Problem solving

Communication

SOP drafting

Microsoft Office

HMI systems

Calibration databases

Education

Bachelor's degree in engineering or related technical field

Graduation by July 2027

Tools

SAP

Job description

Job Description

The Formulation, Laboratory, and Experimentation (FLEx) Center is a new multi-modality (small molecule, biologics, vaccine) Drug Product development and Good Manufacturing Practice (GMP) clinical manufacturing plant in Rahway, New Jersey. FLEx Sterile 2 is a strategic expansion that will increase sterile clinical manufacturing capacity through additional filling, lyophilization, formulation, sterile supply, and supporting utility suites

To enable our Company's ever evolving pipeline the new FLEx Sterile 2 facility will be equipped with leading edge robotic isolators and novel technologies. These technologies will enable speed and flexibility driving drug products from concepts to clinical supplies for our patients. As the facility is currently under construction, the selected candidate will apply her/his relevant experience to contribute to equipment and facility design, system commissioning/qualification, regulatory certification, as well as other workstreams' critical activities to enable facility startup and operational readiness

When operations commence, this individual will partner closely with the formulators, engineers, Quality representatives, and other team members to ensure the quality of the clinical supplies, the scientific rigor of the processes, and ultimately to enable flexibility and speed of our Company's sterile pipeline

Technical Operations (FLEx Tech Ops)

• 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 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.

Operations (FLEx Operations)

• Build foundational, hands‑on sterile manufacturing floor experience by executing sterile operations in formulation, component preparation, filling, lyophilization, inspection, and associated support areas in accordance with approved procedures.

• Develop practical equipment knowledge by preparing, operating, monitoring, cleaning, and supporting troubleshooting of manufacturing systems while maintaining aseptic practices and GMP compliance.

• Gain experience with GMP operations support by completing electronic and paper batch records, logbooks, checklists, standard operating procedures, and other controlled documentation accurately and in real time.

• Build operations‑support experience by contributing deviation investigations, corrective and preventive actions, change controls, SOP development and revision, and implementation of process improvements.

• Develop end‑to‑end understanding of manufacturing operations through material movement, staging, inventory checks, line clearance and coordination of daily floor activities.

Education Minimum Requirements

• 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.

• Candidates must be currently pursuing an eligible degree and preparing to graduate by July 2027.

• Individuals selected will need to be available to start their employment by July 2027.

Required Experience and Skills

• 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, with 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 computer systems and applications, including 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; and wear required cleanroom protective gowning, including respirators.

• Ability to complete all 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, at all times, safe work habits and maintain a safe work environment. Comprehend and comply with all safety and company policies and procedures.

Preferred Experience and Skills

• Internship, co‑op, laboratory, pilot plant, or manufacturing experience in the pharmaceutical, biotechnology, or similarly regulated industry.

• Hands‑on experience gained 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.

Required Skills

Aseptic Handling, Clinical Manufacturing, Engineering Principle, Engineering Standards, Facility Design, GMP Compliance, GMP Validation, Lean Manufacturing, Manufacturing Systems, Microsoft Office

Preferred Skills

GMP Operations, Manufacturing Operations, Manufacturing Process Engineering, Mechanical Engineering

US and Puerto Rico Residents Only

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer

We provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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Employee Status

Regular

Relocation

Domestic

VISA Sponsorship

No

Travel Requirements

10%

Flexible Work Arrangements

Not Applicable

Shift

1st - Day

Valid Driving License

No

Hazardous Material(s)

n/a

Additional location(s)

Additional location(s) Compensation Information

San Francisco Residents Only

We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only

We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance

Salary range for primary location

$71,900.00 - $113,200.00

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits .

Additional location(s): Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.