Senior MES & Historian Implementation Lead (Pharma)

OneAPPS Consulting; Brussel; Hybride; EUR 90 000 - 130 000; Plein temps

Résumé du poste

OneAPPS GmbH in Brussels is seeking a Lead Consultant to drive MES and Werum PAS-X implementation projects across TRD manufacturing sites in a hybrid setup. You will coordinate Manufacturing, Quality, Automation, IT/OT and vendors to ensure compliant, scalable digital manufacturing solutions.

The role requires deep MES and Historian experience in pharma, strong GxP and 21 CFR Part 11 knowledge, and a commitment to audit readiness and cybersecurity within Service Delivery scope.

Qualifications

• Experience implementing MES and Historian in pharma.
• Hands-on Werum PAS-X implementation experience.
• Experience SAP integration and GLIMS integration.
• Knowledge of GxP, 21 CFR Part 11, and CSV lifecycle.
• Familiarity with Data Integrity and Cybersecurity in manufacturing.

Responsabilités

• Lead planning, execution, and delivery of MES and PAS-X projects across TRD sites.
• Drive cross-functional collaboration between Manufacturing, Quality, Automation, DDIT IT/OT, vendors and stakeholders.
• Own scope, schedule, budget, risks, and site readiness for MES deployment.
• Ensure adherence to Security & Compliance policies within Service Delivery scope.
• Deliver standardized Werum PAS-X solutions across TRD sites; ensure audit readiness.

Connaissances

MES & Historian

Werum PAS-X

SAP Integration

GLIMS Integration

GxP

21 CFR Part 11

CSV

Data Integrity

Cybersecurity

OT/IT Integration

Historian Platforms

Outils

SAP Integration

GLIMS Integration

WERUM PAS-X

Description du poste

OneAPPS GmbH in Brussels is seeking a Lead Consultant to drive MES and Werum PAS-X implementation projects across TRD manufacturing sites in a hybrid setup. You will coordinate Manufacturing, Quality, Automation, IT/OT and vendors to ensure compliant, scalable digital manufacturing solutions.

The role requires deep MES and Historian experience in pharma, strong GxP and 21 CFR Part 11 knowledge, and a commitment to audit readiness and cybersecurity within Service Delivery scope.