Validation Engineer (Senior)
- Dublin
- Contract
- Full-time
- 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.
- 4+ years' 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.