Deliver end-to-end GxP and non-GxP control system upgrades and installations for a GMP manufacturing site. Responsibilities include concept studies, costing, change management, scheduling, stakeholder/vendor coordination, URS and IT scope definition, system integrator engagement, FAT/SAT/IOQ oversight, and maintaining lifecycle validation documentation in Kneat. Act as SME for automation validation, hardware/software environments, and client standards.
Position: Automation Project Engineer. Location: Cork, Ireland.
PACIV, a global leader in industrial automation solutions with offices in Ireland, the United States and Puerto Rico, and serving the Life Science, F&B and Utilities industries, is looking for an experienced Automation Project Engineer for a GMP Manufacturing Environment in Cork. This is a site-based role.
Job Overview
The Automation Project Engineer will be responsible for end-to-end delivery of GxP and non-GxP Control System upgrades and new installations.
The Automation Project Engineer is responsible for activities that include the following:
Requirements
Desired
PACIV, a global leader in industrial automation solutions with offices in Ireland, the United States and Puerto Rico, and serving the Life Science, F&B and Utilities industries, is looking for an experienced Automation Project Engineer for a GMP Manufacturing Environment in Cork. This is a site-based role.
Job Overview
The Automation Project Engineer will be responsible for end-to-end delivery of GxP and non-GxP Control System upgrades and new installations.
The Automation Project Engineer is responsible for activities that include the following:
- Concept studies and costing
- Change Management process
- Track Project deliverables
- Develop and manage Project schedule
- Coordinate stakeholders, vendors and contractors during Project delivery
- Develop automation scope of works (URS) in conjunction with the System Owner
- Scope and requisition of supporting site IT infrastructure in conjunction with the IT team (Virtual Servers, IT switches etc.)
- Engage the system integrator
- Manage offsite/onsite automation works (Development, FAT testing, installation, shakedown, SAT & User Acceptance testing)
- Update/Execute/Review/approve Lifecycle documentation on Kneat Electronic Document Management System (FDS, RTM, QAP, QASR, FAT, SAT, IOQ)
- SME for client standards as they relate to Automation Projects validation, hardware, software environments and business processes.
Requirements
- BS in Engineering
- 3 or more years of experience in an Automation Projects delivery role.
- Excellent understanding of cGMP's, SDLC methodologies and LEAN/MPS/ Sigma principles. Excellent facilitation, problem solving, and decision-making skills.
- Demonstrated ability in Project Management.
- Ability to analyze and define business problems, develop business cases, and identify appropriate process and technological solutions is essential
- Applicants must have a valid EU Work Permit and Irish residency, no sponsorship provided.
Desired
- Project experience with Siemens Desigo BMS (Cleanroom Environmental Control and CTU Monitoring),
- Siemens PLCs and HMIs,
- DeltaV, Intouch
- Wonderware SCADA,
- SQL Server
- OSI PI database historian
- Thin/FAT Client Application server architecture
- Fire Alarm & Access Control systems
- 21CFR11 compliance,
- Data Integrity
- Automation Project execution at a GMP manufacturing site.
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