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Validation Engineer

Ref: 9222965

  • €35,000 - €45,000
  • 10 Jun 2021
  • Waterford
  • Perm

An expanding employer in the South has a vacancy for a Validation Engineer at their GMP facility. As part of a small dedicated team you'll work on a diverse range of products including equipment qualification, thermal mapping and CSV. For the right candidate a strong salary and benefits package is on offer for these roles which is on days.

About the Job:

  • Calibration, Installation, Operation & Performance qualification (IOPQ) of Laboratory equipment.
  • Maintenance of schedules: Calibration, Qualification, Preventative Maintenance & re-qualification of equipment.
  • Execution of CSV (GAMP, RA, ERES Assessment) on lab Equipment.
  • Hosting & executing Installation, Operation & Performance qualification (IOPQ) of new equipment.
  • Execution of temperature mapping on CTU (generating protocols, review, approval & execution).
  • Maintain the Validation Helpdesk generating reports & metrics and completing own assignments.
  • Calibration of equipment
  • Checking and signing off external certificates of calibration and generation internal certificates for same.
  • Ensure that all documentation is carried out on time, is accurate and legible and conforms to cGMP.
  • The execution of Temperature control mapping on CTU’s & ambient areas
  • About You:

  • Primary degree in Life Sciences or Engineering
  • At least 2-5 years’ experience in a laboratory or GMP regulated environment is desirable; preferably with Calibration/Validation experience.
  • Previous experience in GMP regulated environment.
  • Awareness of pharmaceutical processes for equipment calibration and validation.
  • Excellent technical writing, communication and organisational skills.
  • Quality oriented with the ability to consistently work to industry and client standards.
  • Experience with documenting analytical data and writing reports.
  • Passionate about quality and customer service.
  • Experience in IOPQ & understanding on GAMP for Lab equipment would be desirable
  • For more on the role call Nigel on 087 3618142 or send your CV for consideration.