Senior MES Project Manager

About SimoTech

SimoTech provides manufacturing automation and IT systems engineering, project management and validation services. We partner with life sciences companies to design, build, operate and optimise critical process automation systems that deliver fast track project delivery, operational efficiency, improve manufacturing agility and achieve regulatory compliance.

Why SimoTech

What is it like to work at SimoTech? With a strong collaborative teamwork culture based on respect, trust and excellence, we play a critical partnering role to our clients’ life-changing supply of products to patients. In return, there is excellent salary, career progression, educational support and much more.

Senior MES Project Manager 1583

SimoTech is seeking an experienced Senior MES Project Manager to lead the end-to-end delivery of a Werum PAS-X Manufacturing Execution System (MES) implementation at a global pharmaceutical manufacturing facility in Cork, embarking on its first MES deployment.

This is a high-visibility role that requires strong project leadership, financial control, and the ability to coordinate complex multi-stakeholder programs in a regulated environment.

Key Responsibilities

• Project Leadership & Governance
  
• Lead the full lifecycle implementation of Werum PAS-X MES, including requirements gathering, design, configuration, testing, validation, and go-live.


• Establish robust project governance frameworks, project charters, and steering committee reporting structures.


• Ensure compliance with GxP and CSV requirements throughout the project lifecycle.
• Cost Management
  
• Develop, manage, and control the project budget, including capital and operational expenditure.


• Track actuals against forecast and proactively manage variances with financial stakeholders.


• Prepare cost-benefit analyses and support business case updates and ROI tracking.


• Collaborate with procurement for vendor contracts, change orders, and payment milestones.
• Schedule Management
  
• Develop and maintain a detailed project schedule, including key milestones, critical paths, dependencies, and resource allocations.


• Proactively identify and mitigate scheduling risks and delays across workstreams (IT, business, validation, vendor).


• Use project tools (e.g., MS Project, Primavera, or equivalent) to manage timelines and resource planning.


• Lead regular schedule reviews with internal and external stakeholders to ensure timely delivery.
• Stakeholder Management
  
• Serve as the central liaison between site leadership, global IT, business functions, and external partners (e.g., Werum, system integrators).


• Lead project steering meetings and manage stakeholder expectations through clear, structured communication.
• Team & Vendor Coordination
  
• Direct the work of multidisciplinary teams (MES engineers, automation, QA, validation, manufacturing).


• Coordinate third-party vendors responsible for PAS-X system delivery and integration.


• Ensure alignment between technical design and operational workflows.
• Change Management & Training
  
• Oversee organizational change management activities, including communication, stakeholder readiness, and end-user training.


• Support business continuity planning to minimize operational disruption during system cutover.
• Compliance & Validation
  
• Ensure all activities align with regulatory expectations (FDA 21 CFR Part 11, EU Annex 11, GAMP5).


• Support and manage validation deliverables, including URS, FS, IQ/OQ/PQ, and traceability matrices.

Qualifications

• Bachelors or Masters degree in Engineering, Computer Science, Life Sciences, or related field.
• 15+ years industry experience, with 5+ years of experience in MES project management.
• Demonstrated experience managing project budgets exceeding €5M and multi-phase delivery schedules.
• Background in pharmaceutical or biotech environmen strong knowledge of GMP, manufacturing ts with operations, and electronic batch records (EBR).
• Track record in delivering projects with Agile and hybrid delivery approaches in regulated environments.
• Project management certification (PMP, PRINCE2, or equivalent) preferred.
• Proficient in project planning tools (MS Project, Primavera, or similar).
• Demonstrated leadership capabilities, with a track record of successfully delivering on MES capital projects.
• Excellent interpersonal and communication skills.
• First-time MES implementation experience (greenfield or brownfield).
• Familiar with system integration between MES and ERP (e.g., SAP), LIMS, SCADA/DCS, WMS, etc.

What SimoTech Can Offer

• Role provides a high degree of autonomy to allow the successful candidate to reach their full potential.
• Develop new skills and enhance technical ability by working with innovative technologies in a multi-disciplined environment.
• Opportunity to work with large corporate clients on exciting capital projects.