We are seeking an MES Production Process Specialist to lead the technical administration and support of our Manufacturing Execution System. You will drive a site-wide digital transformation, transitioning from Weigh & Dispense into full Electronic Batch Records (EBR).
Key Responsibilities:
- Manage MES environments (Production, Test, Validation), including user access, security settings, and master data updates.
- Provide L1/L2 troubleshooting for MES applications, resolving incidents related to system performance, interfaces, and shop-floor workflows to minimize downtime.
- Execute configuration changes and recipe/workflow modifications for aseptic filling, compounding, depyrogenation, and packaging operations.
- Lead CSV activities, including IQ/OQ/PQ execution, regression testing, and change control management in alignment with GxP standards.
- Conduct root cause analysis for recurring issues and implement CAPAs to enhance system stability.
- Support the rollout of MES patches and system upgrades, acting as the technical liaison between Manufacturing, IT, and Quality teams.
Requirements:
- Bachelor's degree in Engineering, Computer Science, IT, or a related technical field.
- Proven track record supporting MES within a regulated pharmaceutical (GxP) environment.
- Direct experience with sterile or aseptic manufacturing operations is highly preferred.
- Hands-on experience with MES platforms (e.g., Werum PAS-X, Siemens Opcenter, Emerson Syncade, or Rockwell FactoryTalk).
- Strong analytical mindset for troubleshooting complex system errors and a deep understanding of electronic batch records (EBR) and shop-floor automation.
This is a full time onsite position, with a shift rotation expected please reach out for more information.
