Full-time
Sr. Validation Engineer
Posted by Katalyst HealthCares & Life Sciences • Wilson, North Carolina, United States
About the Role
Summary :
Top must have's: Life science Domain, Validation Skills, Delta V & MES Validation
Roles & Responsibilities:
• Lead and manage C&Q lifecycle activities including URS, DQ, IQ, OQ, and PQ for automation and process systems.
• Collaborate with cross-functional teams including engineering, QA, manufacturing, and automation to ensure validation deliverables align with project timelines.
• Develop and review validation protocols, reports, and supporting documentation in compliance with FDA, EU standards.
• Utilize tools such as Kneat, GVault, or equivalent systems for document control and validation tracking.
• Provide technical guidance and mentorship to junior validation engineers and contractors.
• Support change control processes and deviation investigations related to validated systems.
• Participate in audits and inspections, providing subject matter expertise on validation pract...
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