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

• Bachelors 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.