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.
Desirable / 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.
Job Title: Automation Project ManagerLocation: Dundalk Ireland Industry: Pharmaceutical / Life SciencesRole OverviewThe Automation Project Manager will lead the delivery of automation and control system projects within a GMP-regulated pharmaceutical manufacturing environment. The role is responsible...
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.
Desirable / 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.
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