Location:
Dublin South, Ireland
Job Category:
EU work permit required:
Yes
Job Reference:
5084736_1749657633
Job Views:
5
Posted:
11.06.2025
Expiry Date:
26.07.2025
Job Description:
Global Biotechnology company – based in south Dublin, Ireland – looking for Validation Engineers (Senior).
The successful candidate will be responsible for ensuring that the Validation activities associated with a Syringe Filling Line for a Sterile fill finish facility are following GMP and Quality Requirements.
The role:
* Generation, execution, review and approval of CQV test Documentation (Factor Acceptance Testing (FAT), Instillation Verification (IV’s), Functional Testing (FT’s), Site Acceptance Testing (SAT) and Performance Qualifications (PQ’s) associated with a Syringe Filling Line.
* Pre-Approve and Post-Approve validation protocols.
* Input into site Validation Master Plans and Standard Operating Procedures (SOP’s)
* Collate and report on relevant validation data/metrics.
* Assist in exceptions and deviation resolution and root cause analysis.
* Reviews Validation planning documents detailing overall strategy for the project.
* Reviews and Approves Qualification summary reports (QSR)
* Generates Validation Summary reports.
Have You:
* 4+ year's experience in Engineering or Validation.
* Technical qualification at third level or equivalent in Engineering.
* Extensive knowledge and demonstrated experience managing Validation activities for Pharmaceutical / Biotechnology projects.
* Experience of sterile / biotech equipment within the pharmaceutical industry is preferred.
* Experience of aseptic processing.
* Experience in GMP.
* Experience using Paperless Qualification Systems is preferred.
* Strong understanding of a risk-based approach to commissioning, qualification and validation within the biotechnology industry.
The successful candidate must have eligible working VISA in Ireland or European Union (EU) passport.
Berkley Life Science & Engineering is a specialist consultancy, recruiting professionals for organizations throughout Ireland, UK & Europe; for more information go to www.berkley-group.com
If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone Aleksas Kremenskas at +353 (0) 87 2727949 or send your profile to akremenskas@berkley-group.com
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