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Senior Validation Engineer

Job description

Senior Validation Engineer

Responsibilities:

  • Generate validation documentation including DV, IQ, OQ, PQ protocols and validation reports, and assist in the execution of protocols
  • Maintain consistency on validation/ qualification approach across projects, ensuring validation documentation is fully compliant with site specific policies/ procedures and regulations, good manufacturing practices and industry regulations
  • Be supportive of, and encouraging of others in the project team, showing flexibility in the delivery of team results
  • Responsibility for delivery of project timelines
  • Ensure all project related issues and deviations are documented and approved
  • Independently performs assignments with instruction limited to results expected.  Determines and develops approach to solutions

 

Experience:

  • Third level qualification in Science or Engineering
  • A minimum of 5 years’ experience in a validation role in a pharmaceutical or medical device industry
  • In depth knowledge of relevant laws and regulations associated with the medical device industry (including FDA 21CFR regulations/ CE)
  • Competent working knowledge of recognized Quality Management Systems (ISO9001/ ISO13485/ ISO14971/ GMP)
  • Working experience of validation computer systems for use in FDA regulated environments
  • Pro-active attitude, excellent organization skills, and ability to manage multiple projects while delivering results on time
  • High understanding of Compliance, Validation Practices including the system development life cycle & Regulations
  • Excellent interpersonal, written and verbal communication skills, including ability to effectively articulate understanding of process science, in order to drive decision making, impact assessments, design of studies etc., in a multi-disciplinary team environment
  • Ability to work as a team player in a consulting environment
  • Proficient with MS Word, Excel, Power Point, and management of spreadsheets

 

 To apply for this position please contact Chloe Walsh at Sigmar Recruitment T: +353 91 455305 E:   chloe.walsh@sigmar.ie  

All applications will be treated with the strictest of confidence.  Sigmar will never forward your CV to a third party without prior consent

 

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