Danaher Corporation Process Engineer in Sunnyvale, California
Provide process engineering sustainment coverage during the day shift ( typically 5 am - 1:30 pm )
Responsible for performing process qualifications for new and existing production lines.
Follow and observe all regulatory requirements (GMP’s, ISO, FDA, internal policies) applicable to area of responsibility.
Apply knowledge of relevant continuous improvement tools and approaches to increase production up-time, minimize unplanned maintenance, minimize work in process inventories (WIP) or plant inventories, and implement cost reduction initiatives across equipment and labor.
Assist in creating and updating manufacturing SOPs/Work Instructions.
Provide training to Manufacturing personnel.
Seek and implement process improvements within Manufacturing.
Recognize machine operating conditions and requirements for optimum production runs and can troubleshoot and resolve basic line performance issues.
Identify constraints in, or non-conformances resulting from, the production process through analysis of material, people and information movement/flow.
Effectively interface with other engineering disciplines, such as Controls & Automation engineering and New Product Introduction teams.
Develop and deliver oral and written communications around process improvement projects.
Organize an analytical approach to problem solving with familiarity with FDA and GMP.
Work within operating procedures to identify, change, justify, and implement process improvements to process capability, equipment availability, and yield improvement.
Utilize and leverage ongoing data and convert information into actionable procedures and reaction/escalation plans aligned with maintaining validated state of Class II and Class III automated equipment.
Develop validation documentation for line extensions and process improvements and is the manufacturing liaison for all process qualifications.
Partner effectively during root cause investigation through resolution with functional representatives of regulatory, automation, molding/tooling, production and quality.
Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here (http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf) .
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