Job Description

The FLEx Center is a new multi-modality (small molecule, biologics, vaccine) Drug Product development and GMP clinical manufacturing plant in Rahway, New Jersey. The FLEx organization has a mission to enable development of our Company’s pipeline products with speed, agility, and rigor. This mission will be accomplished by: 1) Enabling robust formulation and process development with flexible physical and digital infrastructure; 2) Delivering compliant, high quality clinical supplies; 3) Developing talents with a new operating model and promoting a growth mindset.

The FLEx organization is seeking a highly motivated individual to serve the role of MES Specialist. The successful candidate will support the deployment and sustainment of a Manufacturing Execution System (MES) at the FLEx Center to enable Electronic Batch Records (EBR), Electronic Logs (E-Logs), and Weigh & Dispense functionality. The Specialist will help to ensure that the MES system functionality will maximize business benefits and meet operating model principles across all modalities at the FLEx Center in a compliant manner. This is an onsite based role in Rahway, New Jersey and reports to the Systems Process Lead Director at the FLEx Center in the Pharmaceutical Operations and Clinical Supply organization.

Responsibilities of the MES Specialist include but not limited to:

• Become an MES subject matter expert and apply knowledge of manufacturing processes to partner with Process Engineers, Formulators, Operations, and Quality resources, working together with them to design, develop, test, revise, and sustain Electronic Batch Records and enable additional MES functionality as needed.

• Execute the appropriate change control and electronic Master Batch Record life-cycle actions and processes to assure the MES system is in a state of control and compliance.

• Participates in the creation and execution of the site MES SOPs, training strategy, and sustainment for end users of the MES system.

• Identify and implement continuous process improvement opportunities.

• Collaborates and assists with troubleshooting to efficiently resolve manufacturing problems, providing support to ongoing MES system operations. Onsite support will be required during regular business hours, second shift and weekend support possible based on business need.

• Develop knowledge of Quality Systems and Regulatory Standards to collaborate with project teams and their respective Quality units on compliant MES solutions and business processes.

• Gain an in-depth knowledge of MES integration with SAP and acquire sufficient expertise in SAP master data and transactions to effectively troubleshoot interface problems from both the MES and SAP perspectives.

• Coordinate and share best practices with other company sites in the network.

• Assist in internal and external agency inspections, as needed.

Qualifications

Education Minimum Requirement:

• BS or MS degree in Engineering, Pharmaceutical Sciences, Business, or a related field

Required Experience and Skills:

• Strong understanding of manufacturing principles/processes and ability to translate manufacturing requirements into an Automation/Digital Solutions

• Minimum of 2 years of experience in a GMP manufacturing environment

• Ability to work collaboratively as part of a team across various functions in a challenging and changing global environment.

• Proven track record of analytical skills, problem solving, and attention to detail

• High personal integrity, credibility, and energy

• Strong written and verbal communication skills

Preferred Experience and Skills:

• Direct experience with MES systems

• Experience in pharma/sterile manufacturing and Weigh & Dispense operations

• Experience with MES deployment and EBR authoring

• Familiarity with MES integration to SAP and Level 2 production systems

• Proficient in SAP ECC – BOM, Recipe, PV, Process Order execution, Material Handling

• Knowledge of SDLC and computer systems validation

#eligibleforERP

#PSCS

Required Skills:

Accountability, Accountability, Adaptability, Automated Manufacturing Systems, cGMP Guidelines, Communication, Cross-Functional Teamwork, Electronic Batch Records, GMP Compliance, Laboratory Experiments, Mammalian Cell Culture, Management Process, Oral Communications, Personal Initiative, Pharmaceutical Sciences, Pharmacology, Pilot Plant Operations, Process Engineering, Process Optimization, Product Formulation, Project Manufacturing, Rigor, Sales Operations, SAP EHS Management, SAP MES {+ 5 more}

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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EEOC GINA Supplement​

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

$85,600.00 - $134,800.00

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:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

10/28/2025

*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.