Data Validation Specialist

2 weeks ago

Dublin, Dublin City, Ireland beBeeComputer Full time €80,000 - €100,000
Develop Validation Expertise as a CSV Engineer

Deliver validation excellence in laboratory instruments and computer systems. This role involves executing comprehensive validation plans, protocols (IQ/OQ/PQ), and reports to ensure seamless integration of new technology and optimal utilization of current skills within fast-paced projects.

Key Responsibilities:
  • Develop and implement rigorous validation strategies for laboratory instruments and computer systems.
  • Perform thorough risk assessments and impact analyses to determine the validation requirements for new and existing systems.
  • Ensure compliance with regulatory requirements (e.g., FDA, EMA, GxP) and industry standards (e.g., GAMP 5).
  • Collaborate with cross-functional teams, including Quality Assurance, IT, and Laboratory Operations, to ensure successful validation and qualification activities.
  • Maintain and update validation documentation, including validation master plans, standard operating procedures (SOPs), and validation summary reports.
  • Conduct periodic reviews and requalification of laboratory instruments and computer systems to ensure continued compliance.
  • Provide training and support to laboratory personnel on validation and qualification processes.
  • Investigate and resolve validation-related issues and deviations.
Requirements:
  • Bachelor's degree in Engineering, Computer Science, Life Sciences, or a related field.
  • Extensive experience in computer system validation and laboratory instrument qualification.
  • Strong knowledge of regulatory requirements (e.g., FDA 21 CFR Part 11, EU Annex 11) and industry standards (e.g., GAMP 5).
  • Experience with validation of laboratory instruments such as plate readers, liquid handlers, spectrophotometers, and other analytical equipment.
  • Excellent documentation and technical writing skills.
  • Strong analytical and problem-solving abilities.
  • Ability to work independently and as part of a team.
  • Excellent communication and interpersonal skills.

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