Engineering Validation Consultant

5 days ago


Dublin, Dublin City, Ireland Mason Alexander Full time

Mason Alexander is seeking a skilled Validation Engineer to join their Quality & Regulatory team on a permanent basis in Wicklow.

This is a fantastic opportunity to work closely with our team, focusing on performing and executing validation and qualification duties for all projects across the site.

Key responsibilities as a Validation Engineer include:

  1. Development of Installation Qualification and Operations Qualification (IQ and OQ) protocols for all new engineering projects.
  2. Conducting IQ and OQ qualification/validation tests.
  3. Presentation of qualification/validation reports to relevant Q.A. for approval.
  4. Guiding Q.A. personnel on validation requirements for the Engineering Department.
  5. Participating in the Validation Group Meeting and serving as the point of contact for Validation/Quality issues.
  6. Verifying documentation written by Engineering Department members to ensure adherence to Validation protocols and Company policies.
  7. Supporting the Engineering Department on quality/validation issues for specific projects.
  8. Collaborating with Project Engineers and Q.A. personnel to complete project documentation within defined time frames.
  9. Maintaining a library for validation documentation/guidelines.
  10. Managing the Change Control System for the Engineering Department.
  11. Guaranteeing compliance with GAMP Guidelines and Good Weigh Practice while making policy and decision-making for Calibration and Metrology.

Required qualifications:

  • Bachelor's degree in a Scientific/Engineering field.
  • At least 4 years of experience in a Validation position within the pharmaceutical, biotech or medical device industry.

This is a hybrid role requiring 3 days per week on site.


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