Senior MES Engineer – PAS-X

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🏖️ New Jersey – Remote

🏖️ New Jersey – Remote

⏳ Contract/Temporary

🟠 Senior

👷🏻‍♀️ Engineer

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CINCO Engineering

WebsiteLinkedInAll Job Openings

1 - 10 employees

💼 Consulting

🏭 Manufacturing

🧬 Biotechnology

💰 $75k Seed Round on 2020-03

Consulting • Manufacturing • Biotechnology

CINCO Engineering is a Quality Risk Management solution provider focused on the Life Sciences sector. The company helps protect patients by managing risks associated with manufacturing processes in pharmaceuticals and biotechnology. They specialize in software development, validation, and regulatory documentation, ensuring compliance and safety in the manufacturing of life-saving products.

📋 Description

• 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

🎯 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 • Experience supporting biologics, sterile manufacturing, cell & gene therapy, or vaccine production (preferred) • Experience integrating PAS-X with SAP ERP, LIMS, DeltaV, PI Historian, OPC, or other manufacturing systems (preferred) • Knowledge of ISA-95 manufacturing integration standards (preferred) • Experience with software development lifecycle (SDLC), Agile, Waterfall, or Hybrid project methodologies (preferred) • Previous participation in global or multi-site PAS-X implementations (preferred) • Experience supporting regulatory inspections and customer audits (preferred) • Knowledge of serialization, track-and-trace, and digital manufacturing initiatives (preferred) • Experience with cloud or hybrid manufacturing IT architectures is a plus.

🏖️ Benefits

• Flexible work arrangements • Professional development