Senior MES Engineer – PAS-X

This is a fully remote position, open to applicants in New Jersey.

📋 Description

• Oversee the design, configuration, implementation, and support of Werum PAS-X MES solutions for pharmaceutical manufacturing operations.

• Work closely with Manufacturing, Process Engineering, Quality, Validation, Automation, and IT teams to convert business and process requirements into MES functional solutions.

• Set up PAS-X Master Batch Records (MBRs), workflows, electronic forms, material management, equipment integration, and process parameters.

• Assist with full-cycle MES deployment activities, including requirements gathering, solution design, configuration, testing, commissioning, and production support.

• Create and evaluate functional specifications, design documents, configuration specifications, and technical documentation.

• Diagnose MES problems, conduct root cause analysis, and implement effective corrective actions.

• Facilitate system integration with ERP, LIMS, automation (PLC/SCADA), historians, and other manufacturing systems.

• Engage in FAT, SAT, commissioning, qualification, and validation activities to ensure compliance with regulatory standards.

• Ensure MES solutions adhere to GxP requirements, 21 CFR Part 11, Annex 11, and Data Integrity principles.

• Manage change requests, system enhancements, software upgrades, and initiatives for continuous improvement.

• Provide technical leadership during technology transfers, new product introductions, and support for commercial manufacturing.

• Mentor junior engineers and offer technical guidance to project teams and business stakeholders.

⛳️ Requirements

• Bachelor's degree in Engineering, Computer Science, Information Technology, or a related technical field.

• 7+ years of experience in implementing and supporting Manufacturing Execution Systems in regulated pharmaceutical or biotechnology settings.

• 5+ years of hands-on experience with Werum PAS-X MES, including system configuration and deployment.

• Strong knowledge of pharmaceutical manufacturing processes, electronic batch records (EBR), and digital manufacturing concepts.

• Experience in configuring PAS-X Master Batch Records (MBRs), workflows, process logic, and manufacturing recipes.

• Familiarity with GAMP 5, FDA 21 CFR Part 11, Annex 11, and Data Integrity requirements.

• Experience in supporting commissioning, qualification, validation, and production go-live activities.

• Strong analytical and problem-solving skills, with the ability to resolve complex MES issues.

• Excellent communication, documentation, and stakeholder management skills.

• Capacity to manage multiple priorities in a dynamic manufacturing environment.

• Experience with biologics, sterile manufacturing, cell & gene therapy, or vaccine production is preferred.

• Experience integrating PAS-X with SAP ERP, LIMS, DeltaV, PI Historian, OPC, or other manufacturing systems is preferred.

• Knowledge of ISA-95 manufacturing integration standards is preferred.

• Experience with software development lifecycle (SDLC), Agile, Waterfall, or Hybrid project methodologies is preferred.

• Previous involvement in global or multi-site PAS-X implementations is preferred.

• Experience supporting regulatory inspections and customer audits is preferred.

• Knowledge of serialization, track-and-trace, and digital manufacturing initiatives is preferred.

• Experience with cloud or hybrid manufacturing IT architectures is a plus.

🏝️ Benefits

• Flexible work arrangements.

• Professional development opportunities.