Manufacturing Execution Systems; MES Deployment Sr. Specialist; Onsite

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 the speed, agility, and rigor of our Company’s pipeline products. It will do so through
1). Enabling robust formulation and process development with flexible physical and digital infrastructure;
2). Delivering compliant, high quality clinical supplies;
3). Developing talent with a new operating model and promoting a growth mindset.

The FLEx organization is seeking a highly motivated individual to serve as an MES Deployment Senior Specialist. This role supports the deployment, sustainment, and continuous improvement of the Manufacturing Execution System (MES) at the FLEx Center. The successful candidate will lead the implementation and optimization of MES capabilities (e.g., Electronic Batch Records, Electronic Logs, and Weigh & Dispense) and ensure alignment with business processes and compliance requirements.

This position is an onsite role based in New Jersey and reports to the Systems Process Lead Director in the FLEx organization within Pharmaceutical Operations and Clinical Supply.

• Support MES Deployment
  • Lead or contribute to deployment of MES capabilities (E , E-Logs, Weigh & Dispense) within assigned areas or work streams
  • Support alignment of MES solutions with site business processes and technical standards
• Execute E  Design & Lifecycle Activities
  • Design, build, test, and deploy EBRs in alignment with established standards
  • Support ongoing sustainment and optimization of EBRs to meet business needs
• Support Integration Activities
  • Collaborate with IT and automation teams to support SAP–MES integration and system interfaces
  • Troubleshoot and resolve data or interface issues
• Cross-Functional Collaboration
  • Work closely with Process Engineers, Operations, Quality, and IT to gather requirements and support MES implementation
  • Participate in cross-functional project teams
• Continuous Improvement & Sustainment
  • Identify opportunities to improve MES processes and system performance
  • Contribute to maintaining MES in a compliant and validated state
• Training & Documentation
  • Support development of training materials and user support activities
  • Ensure documentation aligns with SDLC and compliance requirements
• Compliance Support
  • Follow cGMP, SOPs, and validation practices
  • Support audit and inspection activities as needed

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

• 5+ years of combined experience in MES deployment/sustainment and pharma manufacturing
• Strong understanding of manufacturing principles/processes and ability to translate manufacturing requirements into digital solutions
• Experience with E  design and MES workflows
• Familiarity with MES integration concepts (e.g., SAP, manufacturing systems)
• Strong collaboration and communication skills
• High personal integrity, credibility, and energy

• Exposure to SDLC and computer systems validation
• Experience in pharmaceutical manufacturing of Non‑Sterile/OSD products
• Continuous improvement mindset

• Adaptability
• Adaptability
• Analytical Testing
• Biopharmaceuticals
• Biopharmaceutics
• Change Agility
• Collaborative Development
• Curriculum Development
• Data Analysis
• Detail‑Oriented
• Deviation Management
• Equipment Qualification
• GMP Compliance
• Good Manufacturing Practices (GMP)
• Immunotherapy
• Manufacturing Processes
• Pharmaceutical Manufacturing
• Process Design
• Process Hazard Analysis (PHA)
• Process Optimization
• Rigor
• Root Cause Analysis (RCA)
• SAP Technical Support
• Strategic Thinking
• Talent Development {+ 2 more}

• Exposure to SDLC and computer systems validation
• Experience in pharmaceutical manufacturing of Non‑Sterile/OSD products
• Continuous improvement mindset

$ - $

We offer a comprehensive package of benefits including medical, dental, vision, health care and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days.

Rahway, New Jersey (onsite)

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.

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06/26/2026

R402409