Sr MES Engineer - PAS-X
Inteldot•Raritan, NJ
About The Position
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.
Requirements
- 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.
Nice To Haves
- 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.
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.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
