Senior Staff Engineer, Global Calibration & Maintenance in San Diego, CA

$150K - $200K(Ladders Estimates)

Illumina Inc   •  

San Diego, CA 92101

Industry: Pharmaceuticals & Biotech

  •  

11 - 15 years

Posted 32 days ago

The Factory of the Future (FoF) Team is a part of Global Quality & Operations and has responsibility for delivering a best-in-class customer experience through the global solutions, systems and processes that the team delivers. As an Illumina Senior Staff Engineer, Global Calibration & Maintenance, you will operate as the key strategic and program lead in driving the development and implementation of our global calibration, maintenance and equipment lifecycle improvement programs. You will work with diverse stakeholders across Operations, Quality & Compliance to deliver a roadmap of improvements to our core calibration & maintenance quality processes.

This person will join a dynamic, fast paced organization with a mission to drive best-in-class solutions through deep collaboration. You will be adept at driving global change to ensure compliance & product quality.

Responsibilities:


  • Deliver a multi-year global strategy, program and related initiatives to transform Illumina's calibration and maintenance processes
  • Lead and facilitate a global Calibration & Maintenance Community of Practice to share best practices and implement change across global sites
  • Develop calibration and maintenance standard work, develop and monitor common KPIs and Metrics related to the C&M process
  • Ensure global alignment and compatibility of local calibration programs. Review and monitor to program standards, by periodic audits and sustained relationships with site leads
  • Manage and maintain global procedures and perform periodic procedure reviews
  • Monitor calibration contracts and purchase orders.
  • Provide coaching and mentoring to site leads on C&M topics
  • Act as the C&M representative on related global projects
  • Maintain global C&M quality improvement plan
  • Support site staff during audits and inspections

Requirements:


  • 10+ years of equipment lifecycle experience in and FDA regulated environment, specifically related to calibration and maintenance
  • 10+ years of experience driving change through process improvement, strategy development and program management methodologies
  • Demonstrated experience leading diverse teams without direct line reporting
  • Experience in the medical device/IVD, pharmaceutical, or biotechnology fields
  • Knowledge and working application of FDA cGMP; ANSI/ISO
  • Ability to multi-task and methodically manage programs & projects
  • Demonstrated strong analytical problem solving (CAPA, Lean, Six Sigma)
  • Excellent communications & interpersonal skills
  • Business process improvement and program management skills
  • Experience with statistics, Statistical Process Control and DOE techniques is a plus
  • Experience with Microsoft Office, SAP PM
  • The ability to discuss technical topics with non-technical people is strongly desired

Experience/Education:


  • Typically requires a minimum of 10+ years of related experience with a Bachelor's degree


Valid Through: 2019-11-13