Computer Systems Validation Engineer

Job description

Are You Ready? CAI is a 100% employee-owned professional services company established in 1996 that has grown to more than 700 people worldwide. We provide commissioning, qualification, validation, startup, project management, and other consulting services associated with operational readiness to FDA-regulated and other mission-critical industries.Our approach is simple—we put the client’s interests first, we don’t stop until it’s right, and we do whatever it takes to get there. Our Foundational Principles: - We act with integrity- We serve each other- We serve society- We work for our future With employee ownership, one person’s success is everyone’s success. We work diligently to accomplish team goals and live our core values: - Team Before Self - Respect for Others - Can-Do Attitude This position could report to Rockville, MD or Frederick, MD Key Responsibilities Documentation & Compliance Author GxP computer validation documentation (e.g., URS, FRS, RTM, summary reports)Generate and execute test protocols and scriptsEnsure adherence to 21 CFR Part 11 and data integrity principlesReview and contribute to validation plans and risk assessments System & Industry Expertise Support CS...