Manufacturing Execution System (MES) Specialist - 2nd Shift

MSD • Rahway, NJ

7d • Onsite

About The Position

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 individual 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 role presents an exciting opportunity to become an MES expert while learning about clinical drug product processing in both Sterile and Non-Sterile modalities. This is an onsite based role on second shift in Rahway, New Jersey and reports to the Systems Process Lead Director at the FLEx Center in the Pharmaceutical Operations and Clinical Supply organization.

Requirements

• B.A./B.S. degree in Engineering, Pharmaceutical Sciences, Business, or equivalent
• 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.
• Ability to don all required gowning and personal protective equipment (e.g. Powered Air Purifying Respirator).
• Proven track record of analytical skills, troubleshooting, and problem solving.
• Effective communication skills, both verbal and written.
• 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 other GxP documents.
• High personal integrity, credibility, and energy

Nice To Haves

• Experience with MES systems
• Experience with GMP clinical manufacturing of Drug Product and Weigh & Dispense operations
• Experience with MES deployment and EBR authoring
• Familiarity with MES integration to SAP and SCADA systems
• Familiarity with SAP ECC – BOM, Recipe, PV, Process Order execution, Material Handling

Responsibilities

• Become an MES subject matter expert to collaborate with and assist operations staff on the ongoing use and troubleshooting of the MES system in both the Sterile and the Non-Sterile modalities at FLEx during second shift. First shift and weekend support possible based on business need.
• Partner with Process Engineers, Formulators, Operations, and Quality resources to design, develop, test, revise, and sustain MES Digital Records and enable additional MES functionality, as needed.
• Execute 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, and sustainment activities for end users of the MES system.
• Identify and implement continuous process improvement opportunities.
• 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 with other company sites in the network to share best practices.
• Assist in internal and external agency inspections, as needed.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level