Senior Cleanroom Engineer
hace 1 mes
Job Description
The 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 validations
- Develop 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 initiatives
- Train, coach, and advise colleagues and new hires as needed for problem solving, risk management, and CER best practices
- Specify, review, and approve consumable operating and cleaning supplies
- Challenge, continuously improve, and document CER cleaning methods, frequency, and efficacy
- Document requirements and assist in evaluating new CER service suppliers for capability, infrastructure, and compliance. Ensure CER service suppliers are trained to relevant ISI procedures
- Drive consistent practices across all sites, domestic and international
- Drive, manage and review environmental and product nonconformance issues
- Subject matter expert for cleanroom operations during quality and regulatory audits, such as FDA, MDSAP, and other governments and agencies
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