Clean Room Principal Engineer (SME)

At Jabil we strive to make ANYTHING POSSIBLE and EVERYTHING BETTER. We are proud to be a trusted partner for the world's top brands, offering comprehensive engineering, manufacturing, and supply chain solutions. With over 50 years of experience across industries and a vast network of over 100 sites worldwide, Jabil combines global reach with local expertise to deliver both scalable and customized solutions. Our commitment extends beyond business success as we strive to build sustainable processes that minimize environmental impact and foster vibrant and diverse communities around the globe.

 

JOB SUMMARY

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.

Additionally duties include but not limited to;

• 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 10 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

·In addition, expert knowledge on ISO 16232, VDA19, and 13485 is required. ·Medical and Automotive Industry requirements are hinged on this know how.

·Certified Six Sigma Black Belt preferred.

·Lead auditor in ISO 13485:2003, preferred.

·Ability to work independently, with minimal supervision or in a team environment.

·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.

·Computer knowledge in Microsoft Office, BCPs and SAP.

·Excellent verbal and written communication skills (Spanish and English).

·Strong negotiation skills

 

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Jabil, including its subsidiaries, is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, religion, national origin, sex, sexual orientation, gender identity, age, disability, genetic information, veteran status, or any other characteristic protected by law.

 

Accessibility Accommodation  

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