Programme Manager GMP Automation & Controls

Dublin
2 months ago
Applications closed

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My client is a Global Biopharmaceutical company with facilities in Dublin and require an experienced Programme Manager to lead automation and control system upgrade projects on their GMP pharmaceutical site.

Initial focus is on Siemens PLC/HMI lifecycle upgrades and associated OT/IT integration, reporting into the site Automation Manager and working cross-functionally with Production, Engineering, Quality and IT.

Core project focus (for this assignment)

Lead a programme of Siemens PLC and HMI upgrade projects.

Upgrade Siemens PLCs from S7-200 and S7-300 to S7-1200 and S7-1500 platforms.

Upgrade HMIs from Siemens TP Comfort panels to Unified Siemens panels.

Plan and execute cutovers, shutdowns and commissioning with minimal impact to manufacturing operations.

Coordinate vendors, Automation, Validation, Operations and IT/OT teams to deliver these upgrades in a GMP environment.

Key responsibilities

End-to-end project management of automation and digital/OT projects: scope, schedule, budget, quality, risk and compliance management.

Lead planning, design, FAT/SAT, commissioning and qualification of automation and control system changes.

Manage legacy control system replacement and lifecycle upgrades, including obsolescence planning.

Act as primary point of contact with specialist automation and IT/OT vendors; manage scope, change control and performance.

Drive integration of plant control systems with manufacturing OT/IT systems (data integrity, monitoring, asset performance, continuous improvement).

Develop and manage project documentation (URS, functional/design specs, test plans, validation docs, business cases, capex submissions).

Lead risk management, stakeholder engagement and regular status reporting to Automation Manager and key stakeholders.

Ensure projects comply with GMP, data integrity requirements, 21 CFR Part 11, Annex 11 and corporate standards.

If you are an experienced Project / Programme Manager with the right to work in Dublin and would like further information please contact me today

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