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.