Werum PAS-X MES Lead / Solution Consultant

Werum PAS-X MES Lead / Solution Consultant

Location: Remote

Duration: 9-12 month

JD

Skills

• Werum PAS-X v3.18 or above
• MES, IOT,L2 systems
• 8-12 years of overall experience in Pharmaceutical Manufacturing, MES and other Digital Manufacturing solutions.
• Minimum 6+ years of hands-on experience in Werum PAS-X MES implementations, MBR designing,rollout and support.
• Strong experience in Pharma and Life Sciences manufacturing environments.
• Experience in global rollouts, MES deployments, upgrades, and go-live support activities.

Key Responsibilities

• Design, develop, configure, and deploy Werum PAS-X MES solutions for pharmaceutical manufacturing operations.
• Lead and support Master Batch Record (MBR), Generic Master Batch Record (GMBR), Electronic Batch Record (EBR) and workflow design activities.
• Perform requirement gathering, fit-gap analysis, solution design, configuration, testing, validation and deployment activities.
• Execute and support MES implementation, rollout, upgrade, cutover, hypercare and go-live activities.
• Work closely with Manufacturing, Quality, Validation, Automation, Engineering, and IT teams to deliver compliant MES solutions.
• Develop and maintain MES libraries, recipes, Electronic Signature Processes (ESP), master data and workflow configurations.
• Ensure compliance with GxP, GMP, FDA 21 CFR Part 11, EU Annex 11, and Data Integrity requirements.
• Participate in User Acceptance Testing (UAT), System Integration Testing (SIT), IQ/OQ/PQ, FAT/SAT, and CSV activities.
• Troubleshoot production issues and provide L2/L3 support for business-critical manufacturing operations.
• Prepare design documents, validation documents, SOPs, configuration specifications, and deployment documentation
• Good knowledge in L2 and other automation systems.