13586 – Lab Validation Engineer – Tipperary Contractor

Purpose:

The PAT & Labs engineer will be responsible for delivery of Process Analytical Technologies and Lab equipment 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 company Manufacturing Division Automation/IT 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 Process Analytical Technologies and Laboratory systems for capital projects
• Develop and/or review System Development Life Cycle (SDLC) deliverables, compliant with company standards.
• The expectation is that this role will grow to be the PAT SME for site project teams. Successful candidate should Coach, mentor and provide technical training to colleagues.
• Understand and educate local project teams on automation standards as they relate to technology selection, system configuration, SDLC, validation, hardware, software environments and business processes.
• Work closely with the QA-IT function to ensure compliance with company Quality standards.
• Provide input to the development of project schedules and document trackers.
• Participate in, and support, relevant project meetings.
• Engage with stakeholders at all levels of projects.
• Ensure that SDLC is appropriately applied

Minimum Qualifications and Experience:

• BS in Engineering, Computer Science, or other technical degree.
• Specific experience in the design, implementation and qualification of Process Analytical technologies is a requirement – SIPAT is preferable, Multivariate analysis, NIR and other technologies.
• Familiarity with real time release using PAT technologies would be advantageous
• Experience with Process Automation systems and/or Laboratory systems in a Life sciences environment is desirable.
• 8+ years experience with 3 or more years of experience in project automation/IT support in a Life Sciences environment with direct technical and SDLC experience.
• Excellent facilitation, problem solving, and decision-making skills.
• Demonstrated ability to analyse and define business problems, develop business cases, and identify appropriate process and technological solutions is essential.
• 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.
• Experience with Laboratory systems such as LIMS, Empower and Nugenesis