Job Title: Automation Project Manager Location: Dundalk, Ireland Industry: Pharmaceutical / Life Sciences Role Overview The Automation Project Manager will lead the delivery of automation and control system projects within a GMP-regulated pharmaceutical manufacturing environment.
The role is responsible for managing project scope, schedule, cost, quality, and risk across automation initiatives including PLC, SCADA, DCS, MES interfaces, and digital transformation projects.
The successful candidate will act as the key interface between Engineering, Automation, IT, Quality, Manufacturing, and external vendors to ensure compliant and on-time project delivery.
Key Responsibilities Lead end-to-end delivery of automation projects supporting pharmaceutical manufacturing, packaging, utilities, and infrastructure systems.
Manage project scope, schedules, budgets, resources, and risks in line with site and corporate project management frameworks.
Coordinate automation system design, implementation, commissioning, and handover, ensuring alignment with GMP and site quality standards.
Act as the primary point of contact for automation vendors, system integrators, and contractors, managing technical deliverables and performance.
Oversee FAT, SAT, commissioning, and start-up activities, ensuring readiness for qualification and operational use.
Drive Computer System Validation (CSV) and compliance activities, including planning, resource coordination, protocol execution, deviations, and final validation closure in accordance with GAMP 5.
Collaborate closely with QA, Manufacturing, Engineering, IT, and Maintenance to align automation solutions with business and regulatory requirements.
Manage change control, deviations, risk assessments, and CAPAs related to automation systems.
Review and approve automation documentation, including URS, FS/DS, risk assessments, validation plans, IQ/OQ protocols, and summary reports.
Provide regular project updates to site leadership and stakeholders, highlighting progress, risks, and mitigation plans.
Support digital transformation initiatives, including data historians, MES integration, and automation standardisation.
Ensure projects are delivered in compliance with health safety, GMP, data integrity (ALCOA+), and cybersecurity requirements.
Required Skills Experience Degree in Engineering, Automation, Electrical, Instrumentation, or related discipline.
Proven experience as an Automation Project Manager within a pharmaceutical, biotech, or regulated manufacturing environment.
Strong understanding of PLC, SCADA, DCS, and automation architectures, with ability to manage technical teams and vendors.
Demonstrated experience managing automation lifecycle activities including design, FAT, SAT, commissioning, and handover.
Solid knowledge of GMP, CSV, and validation principles in regulated environments.
Experience managing multi-disciplinary and cross-functional teams.
Strong project management skills with the ability to manage competing priorities and complex stakeholder environments.
Excellent communication, leadership, and decision-making skills.
D esirable / Nice-to-Have Experience with DeltaV, Rockwell, Siemens, or PCS7 systems.
Exposure to MES, data historians (PI), or digital manufacturing platforms.
Project management certification (PMP, PRINCE2, Agile) or equivalent.
Experience delivering projects on Irish pharmaceutical sites.
Knowledge of automation cybersecurity standards and practices.