Associate Specialist, Engineering (Onsite)

Job Description

Job Description:

The Formulation Laboratory and Experimentation (FLEx) Center in Rahway New Jersey features a cutting-edge sterile drug product cGMP clinical supply manufacturing facility known as FLEx Sterile which is currently in the operational startup phase. The FLEx Sterile facility is poised to play a pivotal role in the long-term success of delivering our clinical pipeline to patients worldwide encompassing a diverse range of product modalities including sterile small molecules biologics vaccines and antibody-drug conjugates (ADCs).

We are seeking an Associate Engineer Technical Operations Engineeringto serve as a key operations specialist in the FLEx Sterile Expansion Project which is nearing the completion of its Detailed Design Phase in the capital project. This expansion project aims to more than double the capacity of the existing FLEx Sterile Facility by adding a second clinical filling/lyophilization suite a formulation suite and a sterile supply suite along with various supporting infrastructure and utilities.

As construction and commissioning and qualification of the expansion project commences the selected candidate will contribute to equipment and facility design system commissioning and qualification and other critical activities necessary for facility startup and operational readiness. This role presents an exciting opportunity to collaborate with our research formulation scientists capital design engineers safety and quality representatives digital and IT teams equipment vendors and other stakeholders. Together you will drive the design aspects conduct risk assessments engage in strategic planning and ensure the successful execution of the project C&Q and startup phases.

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 Companys sterile pipeline.

Key Responsibilities

• Collaborate closely with a diverse range of stakeholders to gain insights into equipment and facility design maintenance troubleshooting operational excellence financial and capital management team building process sciences technical writing and networking.

• Work with a variety of state-of-the-art aseptic drug product formulation filling and lyophilization equipment while completing processes throughout the manufacturing cycle

• Support individual project assignments and aid in facility and process equipment innovation.

• Perform manual and/or automated operations general maintenance troubleshooting and support functions

• Perform aseptic manipulations within Grade A barrier isolation systems

• Contemporaneous record keeping including equipment and area cleaning and use logs and all pertinent batch and/or equipment preparation documentation.

• Identify and addresses compliance environmental safety and process deviations as appropriate while notifying appropriate personnel

• Demonstrate at all times safe work habits and maintain a safe work environment. Comprehend and comply with all safety and company policies and procedures.

• Attend training classes workshops meetings etc. as needed to improve job skills and product-related procedures.

Education Minimum:

• B.A./B.S. in Mechatronics Engineering Automated Sciences Computer Science Biology Chemistry or equivalent by May 2026

Qualifications:

• Ability to do all required gowning and personal protective equipment ex. Powered Air Purifying Respirator.

• Strong attention to detail and documentation skills are required

• Ability to communicate and work in partnership with other employees in a manufacturing environment

• Ability to prepare Standard Operating Procedures and current GXP documents.

• Demonstrated skills in problem-solving and troubleshooting.

• Effective communication skills both verbal and written.

Preferred:

• Experience with smart technologies such as robots automated systems and/or computer integrated manufacturing equipment (mechatronics).

• Experience operating setting up disassembling and adjusting complex equipment e.g. robotics packaging machinery automatic assembling machines

• Knowledge and experience of sterile drug product manufacture equipment and aseptic technique.

• Experience with quality systems

• Experience with new GMP facility startup.

• Knowledge of Investigational drug regulatory requirements.

• Comprehension of Clinical Supply Chain Operations.

• Experience supporting Commissioning Qualification and Validation.

• Experience in supporting quality investigations and change management.

Working conditions:

• This position may have varying hours based on the needs of the business

• Flexibility working overtime is a requirement in manufacturing

• Travel maybe necessary during facility construction/startup

Travel: Up to 10% of the time.

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Sterile2026

FLEx2026

Required Skills:

Preferred Skills:

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Effective September 5 2023 employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week Monday - Thursday although the specific days may vary by site or organization with Friday designated as a remote-working day unless business critical tasks require an on-site Hybrid work model does not apply to and daily in-person attendance is required for field-based positions; facility-based manufacturing-based or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note this Hybrid work model guidance also does not apply to roles that have been designated as remote.

The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees position within the salary range will be based on several factors including but not limited to relevant education qualifications certifications experience skills geographic location government requirements and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive if applicable.

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 can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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

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Merck & Co. Inc. Rahway NJ USA also known as Merck Sharp & Dohme LLC Rahway NJ USA does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place introductions are position specific. Please no phone calls or emails.

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Travel Requirements:

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