Process Engineer II
About The Position
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
Requirements
- 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.
Nice To Haves
- 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.
Responsibilities
- Own and investigate manufacturing related non-conformances, ensuring timely resolution to maintain on-time product delivery.
- Support the piloting team in creating small-scale batches that support R&D and manufacturing efforts.
- 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.
Benefits
- paid time off
- medical/dental/vision insurance
- 401(k)
- bonus/incentive pay
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
