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Validation Quality Engineer

Validation Quality Engineer

Job Title: Validation Quality Engineer
Contract Type: Permanent
Location: Galway
Start Date: ASAP
Duration: 3 month probation, rolling contract
REF: Ref: 10392
Contact Name: Brid Connolly
Contact Email: brid.connolly@icegroup.ie

Job Description

The Role:

Validation Quality Engineer role with our client in Galway. Working as part of the Quality Team, the post-holder will have overall responsibility for ensuring the on-going validation compliance of equipment, systems and processes.

Key Job Responsibilities:

  • Management & Co-ordination of product / process validation activities with internal departments, external contractors, customers & suppliers per the MVP and project plans.
  • Work directly with customer validation representatives to define inputs and requirements to the MVP.
  • Generate validation documentation (MVP, DOE, IQ, OQ, PQ and process characterisation studies & validation reports)
  • Maintain complete and accurate documentary evidence concerning Qualification and Validation exercises.
  • Ensure consistency on validation/qualification approach across systems and projects.  
  • Review and approve changes to equipment, process, utilities, methods and computerised systems to ensure the validation status of equipment is maintained.
  • Ensure validation documents and templates are up-to-date, focusing on continuous improvement.
  • Ensure all results and data are correct and follow-up on any gaps or discrepancies.
  • Assist in the execution of protocols for new product introduction, product transfers, equipment, process, utilities, methods and computerised systems.
  • Review, preparation & approval of deviations and change controls.
  • Conduct equipment, process, and systems validation activities in compliance with US and EU regulations, global procedures and EHS requirements.
  • Maintain on-going understanding and knowledge of the latest regulatory requirements for validation in compliance with EU/U.S. regulations and guidance documents.
  • Provide guidance and direction in the preparation and execution of validation activities, including carrying out training to staff across various functions.
  • Present validation systems at internal and external audits and support quality assurance programmes.
  • Responsible for QMS implementation activities required for new product introduction / product transfers and support the Quality function with any additional assigned QMS activities.

Skill Requirements:

  • Degree in Science/Engineering with 5+ 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 with validation experience preferable.
  • 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 including Minitab use.
  • Experience in completing Gauge R&R Studies and evaluation / analysis.
  • Experience of continuous improvement tools such as Lean Six Sigma (Green Belt qualified).