CREGG is currently seeking a CSV Validation Engineer with experience in an automation platform (Rockwell) within a Pharmaceutical environment on a long-term contract.
This is a site-based role, and a Valid Irish work permit is essential.
Roles and Responsibilities: Act as the SME within CSV as and when needed Participate and lead CSV activities linked to Automation projects Support the preparation of Gx P Computerised System Lifecycle documents, including validation plans, requirement specifications, risk assessments, qualification protocols, requirements traceability matrices, and validation reports.
Design, generat,e and execute test plans and test protocols, managing and reporting findings and non-conformances raised during all types of testing.
Ensure that computer systems and their associated documentation are fully compliant with site specific policies and regulations, good manufacturing practices and industry regulations.
Lead risk assessment before test execution, such risk assessment includes but not limited to ERES assessment, system functional risk assessment.
Responsible for review of the vendor validation documents, such as validation protocols and validation summary reports.
Participate in deviation investigation, analysis and change assessment.
Support key initiatives and offer concise advise on a range of topics linked within the CSV automation space Skills and Education: Third level qualification in Electrical, Electronic, Systems Engineering, Computer Science or Equivalent 5+ years experience working in control systems validation in the Life Sciences/ Pharma sector Excellent communication and technical writing skills Experience of PLC/SCADA and OSIsoft PI Data Historian Validation.
Knowledge of GAMP software development lifecycle, ANSI/ISA-S88 and S95 industry standards and 21 CFR Part 11 A Valid Irish work permit Skills: Validation CSV SCADA Historian