Sr MES Engineer - PAS-X

Inteldot; Raritan (NJ); On-site; USD 140,000 - 200,000; Full time

Job summary

Inteldot is seeking a Senior MES Engineer with extensive Werum PAS-X MES experience in regulated pharmaceutical or biotech environments. You will design, configure, deploy, and support PAS-X solutions enabling digital manufacturing, EBR, and compliant shop floor execution while aligning with business and regulatory requirements.

Responsibilities include leading MES deployments, collaborating with cross-functional teams, configuring MBRs and workflows, and ensuring compliance with GxP and 21 CFR

Qualifications

• 7+ years of MES implementation in regulated pharma/biotech environments.
• 5+ years hands-on Werum PAS-X MES experience including configuration and deployment.
• Knowledge of GxP, 21 CFR Part 11, Annex 11, and Data Integrity.
• Strong communication and documentation skills.
• Experience with validation, commissioning, and production go-live.

Responsibilities

• Lead design, configuration, and support of Werum PAS-X MES solutions for pharmaceutical manufacturing.
• Collaborate with Manufacturing, Process Engineering, Quality, Validation, Automation, and IT to translate requirements into MES functions.
• Configure PAS-X Master Batch Records, workflows, forms, material management, and equipment integration.
• Support end-to-end MES deployment activities: requirements, design, config, testing, commissioning, production support.
• Develop and review functional specs, design documents, and technical docs.
• Troubleshoot MES issues and perform root cause analyses.
• Integrate MES with ERP, LIMS, automation, historians, and other systems.
• Participate in FAT, SAT, commissioning, qualification, and validation activities for compliance.
• Ensure MES solutions comply with GxP, 21 CFR Part 11, Annex 11, Data Integrity.
• Lead change requests, enhancements, upgrades, and continuous improvement.
• Provide technical leadership during transfers, new product introductions, and manufacturing support.
• Mentor junior engineers and guide project teams.

Skills

Analytical thinking

Problem solving

Communication

Education

Bachelor's degree in Engineering or related field

Tools

Werum PAS-X MES

SAP ERP

LIMS

DeltaV

PI Historian

OPC

Job description

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.