Lead Consultant MES and Historian implementation

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 (www.oneapps.com) is a Technology consulting firm based out of Germany and offices across Europe. We are working on various projects involving diverse, multicultural teams with clients across the Europe. We are an invaluable partner and our teams have collaborated to support the growth of our clients. With more than 7 locations worldwide we help our clients to deliver their projects smoothly. We look forward to getting to know you and working with you.

Role: Lead Consultant - MES and Historian implementation

Location: Brussels

Work Mode: Hybrid

Job Description*

• Lead the planning, execution, and successful delivery of Digital Plant and MES Werum PAS-X implementation projects across TRD manufacturing sites, ensuring alignment with business objectives, solution architecture, regulatory requirements, and project governance standards.
• Drive cross-functional collaboration between Manufacturing, Quality, Automation, DDIT IT/OT, vendors, and site stakeholders to deliver compliant, scalable, and user-centric digital manufacturing solutions.
• Take overall accountability for scope, schedule, budget, risks, stakeholder engagement, and site readiness, enabling successful adoption of MES capabilities and supporting the broader TRD digital transformation strategy.
• Take accountability to ensure adherence with Security & Compliance policies and procedures within Service Delivery scope.
• Successfully deliver Digital Plant and MES projects within approved scope, schedule, budget, and quality targets while proactively managing risks, issues, and dependencies.
• Ensure successful deployment and adoption of standardized Werum PAS-X solutions supporting compliant, efficient, and scalable manufacturing operations across TRD sites.
• Maintain full compliance with GxP, CSV, Data Integrity, and Cybersecurity requirements, ensuring audit readiness and minimizing compliance risks.

Mandatory skills*

• MES and Historian implementation in Pharma
• WERUM-PASX implementation
• SAP Integration
• GLIMS Integration
• GxP
• 21 CFR Part 11
• CSV
• Data Integrity
• Cybersecurity
• OT/IT Integration
• Historian Platforms

Desired skills*

• Expert understanding of analysis & design and system architecture concepts and integration patterns for OT/IT.
• Expert understanding of Plant business processes and drug development.
• Expert knowledge of GXP, 21 CFR Part 11 and CSV lifecycle.
• Industry 4.0 initiatives.
• English mandatory, Slovene language skills are an advantage.
• Pharma / Manufacturing / Digital Plant