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Highly Experienced Validation Engineer
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The Validation Engineering Specialist plays a critical role in ensuring our Syringe Filling Line adheres to GMP and Quality Standards.
Main Responsibilities:- Develop, execute, review, and approve CQV test documentation for Factor Acceptance Testing (FAT), Instillation Verification (IV's), Functional Testing (FT's), Site Acceptance Testing (SAT), and Performance Qualifications (PQ's).
- Prioritize and post-approve validation protocols.
- Collaborate on site Validation Master Plans and Standard Operating Procedures (SOP's).
- Analyze and report relevant validation data/metrics.
- Assist in resolving exceptions and deviations, as well as root cause analysis.
- 6+ years of experience in Engineering or Validation.
- Degree qualification at third level or equivalent in Engineering.
- In-depth knowledge and demonstrated experience executing Validation activities for Pharmaceutical / Biotechnology projects.
- Experience with sterile/biotech equipment within the pharmaceutical industry is beneficial.
- Demonstrated strong Communication skills.
Skilled in Factory Acceptance Testing, Sterile fill finish facility, Instillation Verification (IVs), Functional Testing (FTs), Validation Document Review & Approval.
