We are seeking a Senior Validation Specialist to join our team at our sterile fill-finish facility.
This critical role involves ensuring all validation activities related to our Syringe Filling Line are in strict compliance with GMP and our rigorous Quality Requirements.
Key Responsibilities:
* Validation Protocol Management
o Generate, execute, review, and approve CQV test documentation for Syringe Filling Lines.
o Pre-approve and post-approve validation protocols.
* Site Validation Planning
o Input into site Validation Master Plans and Standard Operating Procedures (SOP's).
* Qualification and Reporting
o Collate and report on relevant validation data/metrics.
o Assist in exceptions and deviation resolution and root cause analysis.
* Documentation Review
o Reviews validation planning documents detailing overall strategy for the project.
o Reviews and Approves Qualification Summary Reports (QSR).
o Generates Validation Summary reports.
Requirements:
* Education and Experience
o 6+ years of experience in Engineering or Validation, coupled with a third-level technical qualification (or equivalent) in Engineering.
o Extensive experience executing validation activities for Pharmaceutical/Biotechnology projects.
o Familiarity with sterile/biotech equipment in the pharmaceutical industry is a plus.
* Skills and Knowledge
o Strong knowledge of safety and GMP requirements.
o Demonstrated strong communication skills.
o Experience with Paperless Qualification Systems is preferred.
o A solid understanding of a risk-based approach to commissioning, qualification, and validation in the biotechnology industry.