Senior Cleanroom Engineer

Job DescriptionThe senior cleanroom engineer is the ISI subject matter expert for Controlled Environment Room (CER) regulatory standards and compliance, operational procedures, and industry best practices. Manage and continuously improve CER operating procedures and controls and drive implementation across the organization.
Roles & Responsibilities: Specify and participate in new CER designs, startup, and validationsDevelop CER specifications and operating procedures as needed for new product, process, or regulatory requirements.Review, manage, and approve changes or modifications to CERs, new processes, equipment, and materials.Develop, promote, and implement CER operations training programs and initiativesTrain, coach, and advise colleagues and new hires as needed for problem solving, risk management, and CER best practicesSpecify, review, and approve consumable operating and cleaning suppliesChallenge, continuously improve, and document CER cleaning methods, frequency, and efficacyDocument requirements and assist in evaluating new CER service suppliers for capability, infrastructure, and compliance. Ensure CER service suppliers are trained to relevant ISI proceduresDrive consistent practices across all sites, domestic and internationalDrive, manage and review environmental and product nonconformance issuesSubject matter expert for cleanroom operations during quality and regulatory audits, such as FDA, MDSAP, and other governments and agencies
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