Manufacturing Execution System (MES) Specialist (Onsite)

MSD

76d • $85,600 - $134,800

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 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.

Requirements

• BS or MS degree in Engineering, Pharmaceutical Sciences, Business, or a related field.
• Strong understanding of manufacturing principles/processes and ability to translate manufacturing requirements into 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.

Nice To Haves

• 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.

Responsibilities

• Become an MES subject matter expert and apply knowledge of manufacturing processes to partner with Process Engineers, Formulators, Operations, and Quality resources.
• 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.
• Participate 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.
• Collaborate and assist with troubleshooting to efficiently resolve manufacturing problems, providing support to ongoing MES system operations.
• 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.
• Coordinate and share best practices with other company sites in the network.
• Assist in internal and external agency inspections, as needed.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees