Cleanroom Engineer

Job DescriptionThe cleanroom engineer is the site subject matter expert for Controlled Environment Rooms (CER) regulatory standards and compliance, operational procedures, and industry best practices. Manage and continuously improve existing CER operating procedures and controls.Roles & Responsibilities:Review, manage, and approve changes or modifications to CERs, including the addition of new processes, equipment, or materials.Manage and review environmental and product nonconformance issuesDevelop, promote, and implement CER operations training programs and initiativesTrain, coach, and advise colleagues and new hires as needed for CER best practices, risk management, and problem solving.Drive consistent practices across all CERs onsite.Document requirements and assist in evaluating new CER service suppliers for capability, infrastructure, and compliance. Ensure CER service suppliers are trained to relevant ISI proceduresChallenge, continuously improve, and document CER cleaning methods, frequency, and efficacy.Participate in the development of new CER specifications, commissioning, and validation for new construction.Subject matter expert for cleanroom operations during quality and regulatory audits, such as FDA, MDSAP, and other governments and agencies#J-18808-Ljbffr