Validation Engineer

Galway  ‐ Onsite
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Description

Key Job Responsibilities:
  • Generate validation documentation (URS, IQ, OQ, PQ and process characterisation studies & validation reports) and assist in the execution of protocols for equipment, process, utilities, methods and computerised systems.
  • Generate collection plans for the qualification and acceptance of incoming components including product sub assemblies.
  • Troubleshoot validation issues
  • Ensure consistency on validation/qualification approach across systems and projects.
  • Ensure validation documents are up-to-date
  • Manage the execution of the product/process validation as per the MVP and project plan.
  • Work directly with customer validation representatives to define inputs and requirements to the MVP.
  • Ensure all results and data are correct and follow-up on any gaps or discrepancies.
  • Liaise with the Engineering function to ensure that equipment validation requirements are maintained from Purchase to Qualification of new technology equipment.
  • Provide guidance and direction in the preparation and execution of validation activities, including carrying out training to staff across various functions.
  • Maintain validation procedures and templates up to date, focusing on continuous improvement


Job Requirements:
  • Degree in Science/Engineering with 3+ years experience in a similar role within the Medical Devices or related Healthcare industry.
  • Strong knowledge of ISO and FDA quality requirements.
  • Good understanding of validation concepts and documentation.
  • Strong communication skills, including ability to advise and influence.
  • Excellent attention to detail and report-writing ability
  • Proven ability to work on own initiative.
  • Highly organized with strong ability to prioritize tasks.
  • A general knowledge and experience of statistical analysis methods is an advantage.
Start date
10/2015
Duration
6 months
From
Real Staffing
Published at
03.10.2015
Project ID:
994111
Contract type
Freelance
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