Validation Specialist

5 days ago

Dublin, Dublin City, Ireland CREGG Full time

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.

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, generate 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 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
Qualifications
  • Second level qualifications 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
Seniority level
  • Mid-Senior level
Employment type
  • Full-time
Job function
  • Pharmaceutical Manufacturing

We are not listing role-specific site postings beyond this description. This is a straight CSV validation engineering role focused on lifecycle documentation, testing, and compliance within a pharmaceutical automation environment.


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