Manufacturing Execution System (MES) Specialist (Onsite)

Overview

The FLEx Center is a new multi-modality (small molecule, biologics, vaccine) drug product development and GMP clinical manufacturing plant located in Rahway, New Jersey. Our mission is to enable the development of our pipeline products with speed, agility, and rigor. We achieve this by enabling robust formulation and process development, delivering compliant and high-quality clinical supplies, and developing talent through a new operating model that promotes a growth mindset.

Role Summary

The MES Specialist 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 ensure MES functionality maximizes business benefits and meets operating model principles across all modalities in a compliant manner. This is an onsite role in Rahway, NJ reporting to the Systems Process Lead and Director at the FLEx Center in the Pharmaceutical Operations and Clinical Supply organization.

Responsibilities

• Become an MES subject matter expert and partner with Process Engineers, Formulators, Operations, and Quality resources to design, develop, test, revise, and sustain Electronic Batch Records and enable additional MES functionality as needed.
• Execute change control and electronic Master Batch Record lifecycle actions to ensure the MES system remains controlled and compliant.
• Create and execute MES SOPs, training strategy, and sustainment for end users of the MES system.
• Identify and implement continuous process improvement opportunities.
• Assist troubleshooting to resolve manufacturing problems and support ongoing MES operations. Onsite support during regular business hours, second shift, and weekends may be required.
• 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.
• Acquire expertise in MES integration with SAP, SAP master data, and transactions to troubleshoot interface problems from both 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

Compensation & Benefits

Salary : $85,600.00 – $134,800.00. Eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive benefits package that includes medical, dental, vision, 401(k) with company matching, paid holidays, vacation, and compassionate and sick days. Full benefits details are available at https : / / jobs.merck.com / us / en / compensation-and-benefits

Equal Employment Opportunity

We are an Equal Employment Opportunity Employer. We prohibit discrimination based on race, color, age, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability status, or any other legally protected characteristic. For more information, refer to the EEOC resources.

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