Senior Validation Engineer

• 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.
• Assist in the development of User Requirement Specifications (URS's) and Quality Risk Assessment for Equipment and Automated Systems (QRAES)

• 6+ years of experience in Engineering or Validation, coupled with a third-level technical qualification (or equivalent) in Engineering.
• Extensive experience executing validation activities for Pharmaceutical/Biotechnology projects.
• Familiarity with sterile/biotech equipment in the pharmaceutical industry is a plus.
• Strong knowledge of safety and GMP requirements.
• Demonstrated strong communication skills.
• Experience with Paperless Qualification Systems is preferred.
• A solid understanding of a risk-based approach to commissioning, qualification, and validation in the biotechnology industry.

Morgan McKinley