Principal Engineer - Cleanroom SME

Jabil Inc.-posted 2 months ago
Full-time • Principal
Onsite • San Jose, CA
5,001-10,000 employees
Computer and Electronic Product Manufacturing
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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. How will you make an impact? Jabil has an exciting opportunity for a Cleanroom and Technical Cleanliness Subject Matter Expert (SME) with a focus in a Manufacturing, Technology, and/or Electronics industry environment. The Cleanroom and Technical Cleanliness SME is responsible for establishing, maintaining, governing, and operationalizing cleanliness standards across the organization. You will lead cleanliness activities, conduct cleanliness analyses, and drive continuous technical cleanliness improvements. This includes developing and enforcing contamination control protocols, ensuring compliance with ISO 16232, VDA 19, and ISO 14644, and driving continuous improvement in technical cleanliness for components, assemblies, and manufacturing environments. The SME serves as the central authority on cleanliness requirements, bridging engineering, quality, and operations to uphold world-class standards. This role provides expert guidance on contamination control, cleanroom design and operation, and cleanliness validation for components, assemblies, and processes. This role will be based from our manufacturing facility in San Jose, CA Relocation available 50% travel required (domestic and international)

  • Develop and maintain cleanroom protocols in accordance with ISO 14644, ISO 16232, IEST-RP-CC001/CC002,VDA 19,SEMI E44/F21 and relevant cleanliness standards. and other relevant standards.
  • Develop and enforce SOPs, work instructions, and validation protocols for cleanliness-critical operations.
  • Develop standards / guidelines / best practices on clean room set up and operation in Jabil referencing industry standards.
  • Operationalize cleanliness protocols by integrating them into manufacturing workflows, inspection procedures, and supplier requirements.
  • Maintain and continuously improve cleanliness programs, including documentation, training, and audit readiness.
  • Support the design, layout, and specification of cleanroom systems including HVAC, filtration (HEPA/ULPA), airlocks, gowning areas, and environmental monitoring systems.
  • Review and provide support for cleanroom design documents, drawings, and change requests across Jabil enterprise as required.
  • Provide support for installation and integration of cleanroom systems and ensure construction aligns with defined classifications (ISO 5-8, as required).
  • Lead contamination control initiatives, including cleanroom design, environmental monitoring, and process validation.
  • Responsible for leading technical cleanliness analysis and related activities in the laboratory.
  • Conduct cleanliness assessments and audits of components, equipment, and facilities using ISO 16232-compliant methods.
  • Define cleanliness training content and qualification plans for quality specialists, front line workers and other areas regarding cleanliness.
  • Define resources for cleanliness strategy implementation, including equipment, consumables, headcount, and external alternative providers as needed to maintain equipment, ensuring cleanliness and safety standards.
  • Train and mentor personnel on cleanroom behavior, cleanliness standards, inspection techniques and cleanliness best practices.
  • Interface with suppliers to ensure incoming components meet cleanliness specifications and are validated according to ISO 16232, ISO 14644, and VDA 19.
  • Support root cause investigations and corrective actions related to cleanliness deviations or contamination events.
  • Collaborate with cross-functional teams such as engineering and quality teams to embed cleanliness requirements and controls into product design, development, and manufacturing.
  • Specify and validate cleaning processes for parts and assemblies, including fluid-carrying components.
  • Oversee cleanroom certification, monitoring, and environmental control systems.
  • Interface with suppliers to ensure incoming parts meet ISO 16232 and VDA 19 cleanliness requirements.
  • Create a capability tracker of all clean rooms which can be set up for multiple reasons.
  • Keep abreast with the latest Cleanroom requirements and related technologies.
  • Look for innovative technologies or solutions that support daily basis activities.
  • Promote GMPs and Baselines in the plant(s).
  • Develop and implement quality assurance monitoring procedures on (Particles, temperature, relative humidity, and positive pressure).
  • 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.
  • Support the development and industrialization of analytical methods to improve cleanliness indicators.
  • Communicate and record testing results, communicate findings and risks.
  • Coordinate feasible studies on Cleanroom with consultants and propose qualification criteria on service and speed to build the clean room.
  • Maintain control of the files and records of the viable and non-viable load verification program.
  • Responsible to ensure Cleanroom build requirements meets facilities requirements.
  • Internally coordinate the manufacturing of products and samples necessary to conduct the validations and revalidations.
  • Maintain controlled final reports of clean room validations. (As built, at rest and operational)
  • Participate and provide support during client, corporate or third-party audits.
  • Participate in the internal audit program as internal auditor and/or leader.
  • Bachelor's degree in Engineering, Chemistry, Microbiology, Industrial Hygiene, Material Science, or related technical field (Master's preferred).
  • Minimum 5 years of experience in cleanroom operations and technical cleanliness in a regulated industry (e.g., automotive, aerospace, medical device, semiconductor).
  • Experience with particle measurement techniques, gravimetric analysis, and cleanliness inspection tools.
  • Experience with classification, design, engineering, airflow, wall systems, floors, equipment, hardware, ceilings, quality assurance, viable and non-viable control systems in Cleanrooms.
  • Experience with cleanliness validation in fluid systems or precision assemblies.
  • Familiarity with cleanroom design and HVAC systems.
  • Must be comfortable with 50% travel globally
  • In-depth knowledge of ISO 14644, ISO 16232, IEST-RP-CC001/CC002,VDA 19,SEMI E44/F21 and relevant cleanliness standards.
  • Good knowledge of laboratory analytical instruments, principles, and applications (IR, SEM-EDX, ICP-OES, XRF…).
  • Knowledge of Requirements and Automotive Quality Core Tools (PPAP, MSA, APQP, SPC, FMEA).
  • Knowledge of regulatory requirements (FDA, GMP, ISO 13485).
  • Proficiency in data analysis and reporting tools (Excel, Minitab, etc.).
  • Strong analytical and critical thinking skills.
  • Excellent communication and training abilities.
  • Certification in cleanroom or contamination control (e.g., IEST) is a plus.
  • Certified Cleanroom Professional (CCP or CRCP) or Certified Contamination Control Specialist (CCCS) - preferred
  • Medical, Dental, Prescription Drug, and Vision Insurance with HRA and HSA options
  • 401K Match
  • Employee Stock Purchase Plan
  • Paid Time Off
  • Tuition Reimbursement
  • Life, AD&D, and Disability Insurance
  • Commuter Benefits
  • Employee Assistance Program
  • Pet Insurance
  • Adoption Assistance
  • Annual Merit Increases
  • Community Volunteer Opportunities
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