13853 – Senior CSV Engineer – Meath Contractor

Purpose:

The CSV Engineer will be responsible for delivery of Automation and IT scope on one or more projects in the portfolio of capital projects managed by Global Engineering Solutions (GES). This candidate will be required to work closely with the teams responsible for the full Automation and IT scope and with vendors / partners with responsibility for delivery of systems.

Responsibilities:

• Partner with local project teams to deliver Automation and IT aspects of capital projects
• Liaise with site AIT group to add input to site SOP’s
• Author\Review\Approval of qualification lifecycle documents for process\lab systems – RS, CS, RTM etc…
• Work with site teams on generation of requirement and\or configuration specification, design specifications and test protocols
• Protocol generation, execution and approval
• Maintain Inventory and control upgrades to PLC/SCADA/DCS system
• Generate any automation change control documentation required for introducing new systems or modifying existing systems.
• Generate any risk assessment\variance documentation and interface with above site team to close out same
• Work closely with the QAIT function to ensure compliance with Quality standards.
• Interface with above site teams for deliverables of Enterprise systems as required
• Ensures that SDLC is appropriately applied

Minimum Qualifications and Experience: 

• BS in Engineering, Computer Science, or other technical degree.
• 3 or more years of experience in project/automation/IT support in a similar role.
• Familiar with Annex 11/21CFR Part 11 requirements, GAMP 5 and data integrity guidelines
• Excellent facilitation, problem solving, and decision-making skills.
• Excellent understanding of cGMP’s, SDLC methodologies and LEAN/MPS/ Sigma principles
• Proven facilitation, meeting/workshop management, project management and change management skills are essential.
• Excellent written and oral communication skills, as well as strong presentation skills.
• Demonstrated ability to analyze and define business problems, develop business cases, and identify appropriate process and technological solutions is essential
• Experience in PLC/SCADA/DCS systems