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 GxP 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