Global Pharmaceutical company based in south Dublin, Ireland - looking for
Snr. Validation Engineer
.
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 in compliance with 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)
* 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.
* Assist in the development of User Requirement Specifications (URS's) and Quality Risk Assessment for Equipment and Automated Systems (QRAES).
Have You:
* 6+ year's experience in Engineering or Validation.
* Technical qualification at third level or equivalent in Engineering.
* Extensive knowledge and demonstrated experience executing Validation activities for Pharmaceutical / Biotechnology projects
* Experience of sterile / biotech equipment within the pharmaceutical industry is preferred.
* Knowledge of safety and GMP requirements.
* Demonstrated strong Communication skills
* 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-
If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone Aleksas Kremenskas at or send your profile to -