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.
Skills Required
- BS in Engineering, Computer Science, or other technical degree
- 3+ years experience in Automation Projects delivery
- Excellent understanding of cGMPs, SDLC methodologies, and LEAN/MPS/Six Sigma principles
- Demonstrated Project Management ability
- Ability to analyze business problems, develop business cases, and identify process and technology solutions
- Valid EU work permit and Irish residency (no sponsorship provided)
- Experience with Siemens Desigo BMS (Cleanroom Environmental Control and CTU Monitoring)
- Experience with Siemens PLCs and HMIs
- Experience with DeltaV
- Experience with InTouch
- Experience with Wonderware SCADA
- Experience with SQL Server
- Experience with OSI PI database historian
- Familiarity with Thin/FAT client application server architecture
- Familiarity with Fire Alarm and Access Control systems
- Knowledge of 21CFR11 compliance and Data Integrity principles
- Experience updating/executing validation lifecycle documentation (FDS, RTM, QAP, QASR, FAT, SAT, IOQ) in Kneat
- Automation project execution experience at a GMP manufacturing site
What We Do
PACIV, Inc. (Process Automation – Controls.Instruments.Validations) was founded and registered as a corporation in the Commonwealth of Puerto Rico in 1997. Listening to our clients' desire for local support and standardization among their facilities, we opened our Indiana office (PACIV-USA, LLC) in 2003. Moreover, in 2011 we opened PACIV-Ireland in Cork, Ireland. Our expansion, including international presence with local resources, responds to the needs of our Life Sciences multinational clients regarding replication and consistency of implementation, who demand our life sciences automation and regulatory compliance solutions in a localized market format. Our thorough understanding of the challenges faced by the Life Science sector and our collaborative approach with our clients has enabled us to become a leading Life Sciences automation and regulatory compliance service company. Since our inception, we provide our Life Sciences clients with our services in their multiple manufacturing sites worldwide. The fact that we hold Master Service Agreements (MSA’s) and Preferred Vendor status with the world’s leading Life Science Companies serves a testimony of our quality of service and leadership standing within the Life Science industry. We attract and develop the best talent which allows us to provide our demanding clients with the right knowledge and expertise ensuring we provide significant value within our automation solutions and services.
