Sr. Specialist, Engineering (Onsite)

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 range of product modalities, including sterile small molecules, biologics, vaccines, and antibody-drug conjugates (ADCs).

 

We are seeking a Senior Specialist Engineer, Technical Operations – Engineering, to serve as a key technical 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 Company's sterile pipeline.

 

Key Responsibilities

• Collaborate closely with a 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 with at least 5 years of relevant experience

·       Master’s degree with a minimum of 3 years relevant experience

·       PhD by May 2026

 

Required Experience and Skills:

·       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.

·       Familiarity with United States and European Union cGMP and Safety compliance regulations.

·       Effective interpersonal and communication skills, both verbal and written.

·       Excellent organizational skills to multi-task.

·       Desire and willingness to learn, contribute and lead.

·       Experience in drug product aseptic processing, equipment and aseptic technique.

 

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.

·       Experience supporting electronic batch record (EBR) creation and execution.

 

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.

#eligibleforERP

#PSCS

FLEx2026

Sterile2026

Required Skills:

Adaptability, Analytical Testing, Data Analysis, Detail-Oriented, Deviation Management, Equipment Qualification, Good Manufacturing Practices (GMP), Process Design, Process Hazard Analysis (PHA), Process Optimization, Root Cause Analysis (RCA), Strategic Thinking, Technical Leadership, Technical Problem-Solving, Technical Writing

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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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We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

U.S. Hybrid Work Model

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 presence.This 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

$117,000.00 - $184,200.00

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 employee’s 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 https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (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

Search Firm Representatives Please Read Carefully 
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. 

Employee Status:

Regular

Relocation:

Domestic

VISA Sponsorship:

Yes

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day, 2nd - Evening

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

04/15/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.