Senior QA Validation Specialist

Senior QA Validation Specialist

This innovative speciality biotech organisation is a leading science-based biopharmaceutical company with headquarters based in the U.S that discovers, invents, develops, manufactures, and commercialises medicines for the treatment of serious medical conditions. Employing north of 4,000 staff globally with annual R&D spend of $1 billion, this organisation is consistently being voted one of the top innovative biotech organisations globally year on year. They require an experienced Validation Specialist to join their EU manufacturing facility based in Limerick.

The Position:

  • This person will be responsible for implementing policies and procedures to validate/qualify equipment, systems, and processes in accordance with regulatory requirements and company manufacturing standards.
  • Responsible for compliance monitoring of area operations, including trending of failures and evaluating effectiveness of corrective actions.
  • Generates, executes and reviews master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria.
  • May prepares equipment for qualification studies and executes qualification and validation studies according to approved protocols and SOPs.
  • Analyzes the results of testing and determines the acceptability of results against pre-determined criteria.
  • Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.

The Person:

  • The ideal candidate will have a Degree in Engineering, Chemistry or Life Sciences.
  • Ideally 6+ years experience from a broad validation background; cleaning validation, equipment validation, CSV etc.
  • Further education may substitute for relevant experience.

For more information apply online or contact Ciara O’Brien on + 353 1 6321855.

Salary: On Application Location: Limerick