Project Manager - MES Werum PAS-X implementation

OneAPPS Consulting; Brussel; Hybride; EUR 90 000 - 140 000; Plein temps

Résumé du poste

OneAPPS GmbH in Brussels is seeking a Project Manager to lead Digital Plant and MES Werum PAS-X implementations across TRD manufacturing sites. You will drive cross-functional collaboration among Manufacturing, Quality, Automation, IT/OT, and vendors to ensure compliant, scalable digital manufacturing solutions.

You will be accountable for scope, schedule, budget, risks, and site readiness, enabling adoption of MES capabilities while maintaining regulatory alignment and audit readiness.

Qualifications

• MES and Historian implementation in Pharma.
• WERUM-PASX implementation.
• Program/Project Delivery.
• Manufacturing IT/OT.
• GxP.
• 21 CFR Part 11.
• CSV.
• Data Integrity.
• Cybersecurity.
• Stakeholder Management.
• Site Readiness & Deployment Management.

Responsabilités

• 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.

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: Project Manager

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
• Program/Project Delivery
• Manufacturing IT/OT
• GxP
• 21 CFR Part 11
• CSV
• Data Integrity
• Cybersecurity
• Stakeholder Management
• Site Readiness & Deployment Management

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