Process Engineer II

Process Engineer II

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

Within Danaher Diagnostics, one of Danaher's three segments, our work saves lives—and we're all united by a shared commitment to innovate for tangible impact.

You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's 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 23,000 team members, across 6 operating companies globally, proudly push the boundaries of what's 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 happens—from a family physician's 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 world's biggest health challenges such as cardiac disease, infectious disease, and cancer. At the Diagnostics platform at Danaher, you'll 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:

• Bachelor's degree in Microbiology, Biomedical Engineering, or science related field, with 3+ years' experience OR Master's 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.

Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's 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.

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.