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.
Within Danaher Diagnostics, we offer a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's 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 $74,000 - $90,000. 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 Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law.
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