About the role:
We're looking for a Validation Engineer to join our clients team at our sterile fill-finish facility. In this critical role, you'll be responsible for ensuring all validation activities related to our Syringe Filling Line are in strict compliance with GMP and our rigorous Quality Requirements.
Key Responsibilities:
- 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)
Education/Experience:
- 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.
