The CRPE acts as the GPO for all future Clean Room requirements and GMP (Good Manufacturing Practice) in Jabil Factories Globally. Deep understanding of ISO standards that relate to worldwide requirements is key. Clean Room Key areas of focus are Classification, Design, Engineering, Airflow, Wall Systems, Flooring, Equipment, Hardware, Ceilings, CGMP Monitoring Systems and Maintenance. The CRPE will report into the AMT organization and provide technical strategic and tactical need on Cleanroom expertise. The industry focus would be on EV and OSAT type operations. ESSENTIAL DUTIES AND RESPONSIBILITIES This resource will preferably have a process engineering background who has worked with facilities and quality very extensively to build, operate and maintain clean room environments. Develop standards / guidelines / best practices on clean room set and operation in Jabil referencing industry standards. Support BUs and sites in the construction, operation and maintenance of clean rooms. Create a capability tracker of all clean rooms which can be used for multiple reasons. Keep abreast with latest Cleanroom requirements and related technologies. Promote GMPs and Baselines in the plant(s). Ensure Cleanroom controls meet local facilities and product requirements. Establish formal and periodic contact with Manufacturing support areas. Control, verify and maintain compliance with local and international standards as applicable to the business unit. Coordinate feasible studies on Cleanroom with consultants and propose qualification criterions on service and speed to build the clean room. Maintain control of the files, records and records of the biological load verification program. Responsible to ensure Cleanroom build requirements meets facilities requirements. Internally coordinate the manufacturing of products and samples necessary to carry out the sterilization of validations and revalidations. Maintain controlled final reports of clean room validations. Participate and provide support during client, corporate or third-party audits. Participate in the internal audit program as internal auditor and/or leader. Support new product introduction (NPI) projects that involve cleanrooms requirements. Avalability to travel. EDUCATION & EXPERIENCE REQUIREMENTS Professional degree in science, chemistry, engineering or one of the physical sciences preferred. 5 to 8 years collective experience in building/maintaining/managing Clean Rooms. Knowledge of Clean Room standards US FDE 209E, ISO 14644-1 (c/w Design Requirements) and GMP Annex European Community Cleanroom Standards. Knowledge on ISO 16232, VDA19, and 13485 is required. HVAC System. Automotive Industry requirements are hinged on this know how. Certified Six Sigma Black Belt preferred. Lead auditor in ISO 13485:2003, preferred. High degree of cultural sensitivity due to multinational workforce mix. Ability to collect, organize, structure and write documented regulatory information in an understandable and useful manner. Computer knowledge in Microsoft Office, BCPs and SAP. Excellent verbal and written communication skills (Spanish and English).
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