SR MES ENGINEER - PAS-X

Position Overview We are seeking an experienced Senior MES Engineer with extensive expertise in Werum PAS-X Manufacturing Execution System (MES) implementations within regulated pharmaceutical and biotechnology manufacturing environments. This role will be responsible for designing, configuring, deploying, and supporting PAS-X solutions that enable digital manufacturing, electronic batch records (EBR), and compliant shop floor execution while ensuring alignment with business, manufacturing, and regulatory requirements. Key Responsibilities • Lead the design, configuration, implementation, and support of Werum PAS-X MES solutions for pharmaceutical manufacturing operations. • Collaborate with Manufacturing, Process Engineering, Quality, Validation, Automation, and IT teams to translate business and process requirements into MES functional solutions. • Configure PAS-X Master Batch Records (MBRs), workflows, electronic forms, material management, equipment integration, and process parameters. • Support end-to-end MES deployment activities, including requirements gathering, solution design, configuration, testing, commissioning, and production support. • Develop and review functional specifications, design documents, configuration specifications, and technical documentation. • Troubleshoot MES issues, perform root cause analysis, and implement sustainable corrective actions. • Support system integration with ERP, LIMS, automation (PLC/SCADA), historians, and other manufacturing systems. • Participate in FAT, SAT, commissioning, qualification, and validation activities to ensure regulatory compliance. • Ensure MES solutions comply with GxP requirements, 21 CFR Part 11, Annex 11, and Data Integrity principles. • Lead change requests, system enhancements, software upgrades, and continuous improvement initiatives. • Provide technical leadership during technology transfers, new product introductions, and commercial manufacturing support. • Mentor junior engineers and provide technical guidance to project teams and business stakeholders. Required Qualifications • Bachelor's degree in Engineering, Computer Science, Information Technology, or related technical discipline. • 7+ years of experience implementing and supporting Manufacturing Execution Systems within regulated pharmaceutical or biotechnology environments. • 5+ years of hands-on experience with Werum PAS-X MES , including system configuration and deployment. • Strong understanding of pharmaceutical manufacturing processes, electronic batch records (EBR), and digital manufacturing concepts. • Experience configuring PAS-X Master Batch Records (MBRs), workflows, process logic, and manufacturing recipes. • Working knowledge of GAMP 5, FDA 21 CFR Part 11, Annex 11, and Data Integrity requirements. • Experience supporting commissioning, qualification, validation, and production go-live activities. • Strong analytical and problem-solving skills with the ability to troubleshoot complex MES issues. • Excellent communication, documentation, and stakeholder management skills. • Ability to manage multiple priorities in a fast-paced manufacturing environment. Preferred Qualifications • Experience supporting biologics, sterile manufacturing, cell & gene therapy, or vaccine production. • Experience integrating PAS-X with SAP ERP, LIMS, DeltaV, PI Historian, OPC, or other manufacturing systems. • Knowledge of ISA-95 manufacturing integration standards. • Experience with software development lifecycle (SDLC), Agile, Waterfall, or Hybrid project methodologies. • Previous participation in global or multi-site PAS-X implementations. • Experience supporting regulatory inspections and customer audits. • Knowledge of serialization, track-and-trace, and digital manufacturing initiatives. • Experience with cloud or hybrid manufacturing IT architectures is a plus.