Validation Engineer

About CAI:   CAI was established in 1996; it has grown year over year to more than 750 people worldwide. We provide commissioning, qualification, validation, start-up, project management and consulting services related to operational readiness to FDA regulated and other mission critical industries.   Are you ready?   Our approach is simple; we put the client’s interests first, we do not stop until it is right, and we will do whatever it takes to get there.  At CAI, we are committed to living our Foundational Principles, both professionally and personally: •                 We act with integrity •                 We serve each other •                 We serve society •                 We work for our future. We strongly believe that one person’s success is everyone’s success; we work diligently to accomplish team goals. We place Team Before Self, demonstrate Respect for Others, and possess a can-do attitude. That is how we have grown exponentially.   Requirements Include   Led end-to-end CQV and CSV lifecycle activities, including URS, risk assessments, IQ/OQ/PQ execution, and final reporting for GMP-regulated environments. Executed risk-based validation strategies compliant with FDA 21 CFR Part 11, EU Annex 11, and GAMP 5. Managed Commissioning of Plant Utilities, Commissioning and qualification of clean utilities, process equipment, HVAC systems, Automation and computerized systems for Biotech API and Fill Finish facilities. Experienced in commissioning, qualification, and