Lead Validation Engineer at Remote, Remote, USA |
Email: [email protected] |
Lead Validation Engineer Indianapolis, IN Develop and lead the execution of validation strategies for equipment, processes, software systems, and manufacturing facilities in accordance with regulatory standards. Oversee the validation of critical systems such as sterilization, packaging, and environmental control systems, ensuring their reliability and effectiveness. Lead validation efforts for software-controlled systems, adhering to FDA 21 CFR Part 11 and GAMP 5 guidelines. Experience in validation engineering, specifically within the medical device industry. Deep understanding of validation protocols (IQ/OQ/PQ) and their application in medical device manufacturing environments. Strong problem-solving, analytical, and communication skills. Ability to manage multiple validation projects and meet tight deadlines in a fast-paced environment. -- Keywords: information technology Lead Validation Engineer [email protected] |
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Fri Oct 04 22:13:00 UTC 2024 |