MES project Manager

• Proven experience delivering MES projects end-to-end within GMP-regulated pharmaceutical, biotechnology, medical device or life sciences manufacturing.
• Experience managing projects from scoping and planning through build, testing, validation, cutover, go-live and hypercare.
• Good working understanding of electronic batch records and MES-enabled manufacturing processes.

Project Management

• Strong project management capability covering:
  • Integrated project planning
  • Schedule and critical-path management
  • Budget and resource management
  • RAID management
  • Scope and change control
  • Governance and executive reporting
• Recognised project management qualification such as PMP, PRINCE2, APM or equivalent demonstrable experience.

GMP & Validation

• Working knowledge of GAMP 5 and computer system validation principles.
• Good understanding of 21 CFR Part 11, EU GMP Annex 11/15 and electronic records requirements.
• Ability to manage Quality and Validation workstreams without personally performing technical configuration or validation execution.

Cross-Functional Leadership

• Experience managing multidisciplinary teams across Manufacturing Operations, Quality, Validation, IT/OT, Engineering and external vendors.
• Strong stakeholder management skills, including confidence working with Site Heads, sponsors and senior programme leadership.
• Ability to manage complex dependencies and maintain delivery momentum across geographically distributed teams.

Delivery Methodologies

• Good understanding of Agile delivery approaches including Scrum, Kanban or Lean and how these can be applied within regulated system implementation programmes.

Strongly Preferred

• Direct project delivery experience with Rockwell Automation PharmaSuite MES.
• Experience delivering MES projects within a defined global programme framework and standard configuration.
• Experience managing multiple site deployment projects concurrently.
• Experience with electronic batch record implementation and manufacturing process digitalisation.
• Certified ScrumMaster, PMI-ACP or equivalent Agile qualification.
• Familiarity with MES integration points such as:
  • SAP / ERP
  • TrackWise or Quality systems
  • Process historians such as AVEVA PI
  • Equipment and automation systems
  • Laboratory and manufacturing data systems
• Experience working across a global pharmaceutical manufacturing network.