Global Biotechnology company, based in south Dublin, Ireland – looking for 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:
1. Generation, execution, review and approval of CQV test Documentation (Factor Acceptance Testing (FAT), Installation Verification (IV’s), Functional Testing (FT’s), Site Acceptance Testing (SAT) and Performance Qualifications (PQ’s) associated with a Syringe Filling Line.
2. Pre-Approve and Post-Approve validation protocols.
3. Input into site Validation Master Plans and Standard Operating Procedures (SOP’s).
4. Collate and Report on relevant validation data/metrics.
5. Assist in exceptions and deviation resolution and root cause analysis.
6. Reviews Validation planning documents detailing overall strategy for the project.
7. Reviews and Approves Qualification summary reports (QSR).
8. Generates Validation Summary reports.
9. Assist in the development of User Requirement Specifications (URS’s) and Quality Risk Assessment for Equipment and Automated Systems (QRAES).
Have You:
1. 6+ year's experience in Engineering or Validation.
2. Technical qualification at third level or equivalent in Engineering.
3. Extensive knowledge and demonstrated experience executing Validation activities for Pharmaceutical / Biotechnology projects.
4. Experience of sterile / biotech equipment within the pharmaceutical industry is preferred.
5. Knowledge of safety and GMP requirements.
6. Demonstrated strong Communication skills.
7. Experience using Paperless Qualification Systems is preferred.
8. 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. #J-18808-Ljbffr