Senior Data Validation Specialist

1 week ago

Cork, Cork, Ireland beBeeCsv Full time €120,000 - €130,000

Lead CSV Engineer Job Overview

Main Responsibilities:
  • Manage the qualification of GxP Computerised Systems involved in plant expansion and improvement projects.
  • Design, commissioning, qualification, and validation documentation – drafting, reviewing, and approving CSV related elements of documentation as appropriate.
  • Co-ordinate and execute CSV related commissioning, qualification, and validation activities where applicable, including preparing of validation master plans and executing of DQ, FATs, and SATs.
  • Contribute to the scheduling, tracking, reporting, and achieving of project deadlines.
Key Skills and Qualifications:
  • Degree level qualification in Science, Engineering or equivalent.
  • 10+ years of CSV experience in Pharmaceuticals or Biopharmaceuticals.
  • Experience in process automation.
  • Understanding and experience in GAMP, GDP AND cGMP environments.
  • Experience with ISA S95 and S88 standards.
  • Experience of testing GAMP Category 3, 4 & 5 systems.
  • Knowledge of CFR 21 Part11.
  • Solid organisational skills including attention to detail and multitasking skills.

We are seeking a seasoned Lead CSV Engineer to join our team on a global capital project based in Cork. As a key member of our team, you'll be responsible for managing the qualification of GxP Computerised Systems involved in plant expansion and improvement projects.

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