Program Manager - Manufacturing Execution System (MES) and Digital Manufacturing

Remote working

Project Overview

We are seeking an experienced Program Manager to lead strategic Manufacturing Execution System (MES) and Digital Manufacturing initiatives within a global Life Sciences organization.

The Program Manager will oversee multiple interconnected projects involving MES implementation, modernization, integration, validation, deployment, and site adoption. This role will ensure that manufacturing digital transformation initiatives are delivered within scope, schedule, budget, quality, and regulatory expectations.

The ideal candidate will have strong experience managing complex, multi-site manufacturing technology programs and working with Manufacturing, Quality, Engineering, Validation, IT, Supply Chain, and external system integration partners.

Key Responsibilities

Program Leadership

- Lead end-to-end delivery of MES and Digital Manufacturing programs across multiple manufacturing sites.
- Define the program roadmap, scope, objectives, milestones, delivery approach, and success measures.
- Manage multiple related projects, workstreams, and dependencies under the overall program.
- Ensure alignment between program deliverables, business objectives, and enterprise digital manufacturing strategy.
- Establish program governance, decision-making forums, and escalation processes.

MES and Digital Manufacturing Delivery
- Manage MES implementation, upgrade, rollout, migration, and optimization initiatives.
- Support manufacturing digital transformation capabilities such as:

- Electronic Batch Records
- Paperless Manufacturing
- Manufacturing Operations Management
- Production Scheduling
- Work Instructions
- Material Tracking
- Equipment Integration
- Manufacturing Analytics
- Review by Exception
- Coordinate integration of MES with SAP or ERP, LIMS, QMS, SCADA, PLC, historians, warehouse systems, and other manufacturing applications.
- Drive process standardization and solution harmonization across global manufacturing sites.

Program Planning and Execution
- Develop and maintain integrated program plans, schedules, budgets, resource plans, and delivery forecasts.
- Track milestones, critical paths, risks, issues, assumptions, and dependencies.
- Coordinate business, functional, technical, validation, infrastructure, cybersecurity, and deployment teams.




- Ensure timely completion of design, configuration, integration, testing, validation, cutover, deployment, and hypercare activities.
- Manage program changes through formal scope and change-control processes.

Stakeholder Management
- Partner with Manufacturing, Quality, Engineering, IT, Validation, Supply Chain, and site leadership.
- Facilitate steering committee meetings, governance reviews, and executive status discussions.
- Provide clear reporting on program health, delivery progress, financials, risks, decisions, and business outcomes.
- Build alignment across global and site-level stakeholders.
- Manage expectations and resolve conflicts across business, technology, and vendor teams.

Risk, Quality, and Compliance
- Ensure program delivery complies with applicable Life Sciences standards and regulations, including:

- GxP
- FDA 21 CFR Part 11
- EU Annex 11
- GAMP 5
- ALCOA+ data integrity principles
- Computer System Validation
- Computer Software Assurance
- Partner with Quality and Validation teams to ensure proper documentation, traceability, testing, and approval.
- Support inspection readiness, audit requests, and remediation activities.
- Proactively identify and mitigate delivery, compliance, operational, and technical risks.

Financial and Vendor Management
- Manage program budgets, forecasts, purchase orders, contracts, and financial performance.
- Oversee system integrators, software vendors, consultants, and managed service providers.
- Monitor vendor milestones, deliverables, service levels, and contractual commitments.
- Manage Statements of Work, resource capacity, and commercial dependencies.
- Track program benefits, operational improvements, and value realization.

Change Management and Adoption
- Drive organizational readiness, communication, training, and user-adoption activities.
- Coordinate site readiness assessments, deployment planning, cutover, and hypercare.
- Work with business process owners to ensure new processes and systems are effectively adopted.




- Monitor post-deployment performance and support transition to operations.

Required Qualifications

- Bachelor's degree in Engineering, Information Technology, Computer Science, Life Sciences, or a related discipline.
- 10 15+ years of overall experience in IT, manufacturing systems, digital transformation, or program management.
- At least 5 years of experience managing large MES or Digital Manufacturing programs.
- 5+ years of solid experience in the Pharmaceutical, Biotechnology, Medical Devices, or broader Life Sciences industry.
- 5+ years of proven experience leading global or multi-site technology implementations.
- 5+ years of demonstrated ability to manage complex programs involving business, technology, validation, and vendor teams.
- 5+ years of strong understanding of regulated manufacturing environments and system lifecycle requirements.

Required Functional and Technical Expertise
- Manufacturing Execution Systems
- Digital Manufacturing
- Manufacturing Operations Management
- Electronic Batch Records
- Paperless Manufacturing
- Manufacturing Systems Integration
- Program and Project Management
- GxP and Computer System Validation
- Multi-site Deployment
- Vendor and Financial Management
- Executive Stakeholder Management
- Risk and Dependency Management
- Organizational Change Management

Preferred Platform Experience

Experience with one or more of the following is preferred:

- K rber Werum PAS-X
- Rockwell Automation PharmaSuite
- Siemens Opcenter Execution Pharma
- Emerson Syncade
- SAP Digital Manufacturing
- SAP MII
- AVEVA MES
- FactoryTalk ProductionCentre
- Ignition
- Manufacturing historians and SCADA platforms

Preferred Certifications

- PMP
- PgMP
- SAFe Agilist or SAFe Program Consultant
- ITIL Foundation
- Lean Six Sigma Green Belt or Black Belt
- Agile or Scrum certification

Key Skills

- Program Management
- MES
- Digital Manufacturing
- Manufacturing Operations Management
- Electronic Batch Records
- Paperless Manufacturing
- Life Sciences
- Pharmaceutical Manufacturing
- GxP
- FDA 21 CFR Part 11
- EU Annex 11
- GAMP 5
- CSV
- CSA
- SAP Integration
- LIMS and QMS Integration
- Multi-site Deployment
- Executive Stakeholder Management
- Vendor Management
- Budget Management
- Risk Management
- Change Management
- Digital Transformation

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📌 Program Manager - Manufacturing Execution System (MES) and Digital Manufacturing (Canada)
🏢 United Software Group
📍 Canada