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Validation Engineer

2 weeks ago

Dublin, Dublin City, Ireland Team Horizon Full time

Team Horizon is seeking an experienced Validation Engineer to support a new syringe filling line project at our client's manufacturing facility in Dublin.
Why you should apply: This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients globally.What you will be doing: 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.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.Review Validation planning documents detailing overall strategy for the project.Review and approve Qualification summary reports (QSR).Generate Validation Summary reports.Assist in the development of User Requirement Specifications (URS's) and Quality Risk Assessment for Equipment and Automated Systems (QRAES).What you need to apply: 6+ years 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.
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