SKILLS BRIEF:

• Strong experience in CSV for manufacturing systems and large-scale applications.
• Full understanding of cGMP requirements including 21 CFR 11 and Annex 11.
• Excellent understanding of GAMP principles and validation concepts
• Experience with Trackwise validation an advantage.
• Demonstrated analytical and problem-solving capabilities.
• Strong technical writing skills.

THE ROLE:

• Senior CSV Engineer
• Dublin
• Onsite / Remote Hybrid
• Permanent or Contractor opportunity

ROLE BRIEF:

Responsible for leading and executing validation strategies for key software systems and infrastructure i.e. MES, ERP and QMS. Advise clients in planning, monitoring and execution of program rollouts. Help optimize and streamline manufacturing related operations. Build relationships with clients and identify new business opportunities.