Process Engineer II

Bring more to life.

Are you ready to accelerate your potential and make a real difference within life sciences diagnostics and biotechnology

Within Danaher Diagnostics one of Danahers three segments our work saves livesand were all united by a shared commitment to innovate for tangible impact.

Youll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danahers system of continuous improvement you help turn ideas into impact innovating at the speed of life.

The Diagnostics Platform of Danaher Corporation works with conviction that every moment matters and realize that behind every test is a patient waiting for an answer that could change their life. Our 23000 team members across 6 operating companies globally proudly push the boundaries of whats possible in safeguarding patient health and improving diagnostic confidence. We develop tools and technologies that set the standard for innovation and impact wherever health care happensfrom a family physicians office to leading trauma hospitals and laboratories. Our teams collaborate in an inclusive environment as we connect our people processes and expertise focused on the worlds biggest health challenges such as cardiac disease infectious disease and cancer. At the Diagnostics platform at Danaher youll thrive and quickly see the impact of your contribution.

Learn about the Danaher Business System which makes everything possible.

The Process Engineer II is responsible for owning and investigating manufacturing related non-conformances ensuring timely resolution to maintain on-time product delivery. Additionally they will support the piloting team in creating small-scale batches that support R&D and manufacturing efforts.

This position reports to the Manager NPI and OEM and is part of the Manufacturing Technical Operations team located in West Sacramento and will be an on-site role.

In this role you will have the opportunity to:

• Support Internal Quality KPI-Leads and resolve Internal Non-conformance investigations (assessment of non-conforming product root cause investigations corrective and preventative actions)
• Provide technical support for Operations (Design of experiments technical writing analytical testing (HPLC UV-Vis Spectroscopy and bioassay))
• Support Factory OTD and schedule attainment of finished products
• Lead and resolve customer manufacturing related CAPA and PLRA (post launch risk assessment)
• Support manufacturing of pilot runs and troubleshoot associated deviations

The essential requirements of the job include:

• Bachelors degree in Microbiology Biomedical Engineering or science related field with 3 years experience OR Masters degree in field with 0 years experience
• Experience working in medical device manufacturing pharmaceutical or other regulated environment.
• Demonstrate skills in root cause investigation problem solving implementing corrective actions.
• Excellent written and oral communication of technical data and ability to lead productive team meetings.
• Work with cross-functional teams to investigate manufacturing defects perform data analysis and write informed risk based technical justifications for product release.

It would be a plus if you also possess previous experience in:

• Hands-on laboratory experience in Microbiology or other biological science including exposure to biological sample preparation cell culture analytical assays such as HPLC UV-VIS spectrophotometry etc.
• Danaher Business System (visual project management value stream mapping standard work ) /Lean/Kaizen/6-sigma Problem Solving Process (PSP)
• Risk management process validation design of experiments and design change.

Within Danaher Diagnostics we offer a broad array of comprehensive competitive benefit programs that add value to our lives. Whether its a health care program or paid time off our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.

The salary range OR the hourly range for this role is $74000 - $90000. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future.

This job is also eligible for bonus/incentive pay.

We offer comprehensive package of benefits including paid time off medical/dental/vision insurance and 401(k) to eligible employees.

Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commission benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole discretion unless and until paid and may be modified at the Companys sole discretion consistent with the law.

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Join our winning team today. Together well accelerate the real-life impact of tomorrows science and technology. We partner with customers across the globe to help them solve their most complex challenges architecting solutions that bring the power of science to life.

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