About the position
As the Bio-Rad Manufacturing Engineer I, you will support production by resolving complex manufacturing challenges, investigate non-conformances/deviations and work on process improvement projects. You will be the Subject Matter Expert in the processes associated with Immunoassays, both ELISA and Bead-based including Raw Material Qualification, Bio-Conjugation, and Protein Purification. This knowledge will be applied towards documenting Non-Conformances, Deviation Reports, and CAPAs independently to ensure compliance. Manufacturing Engineers work in a team environment (Quality Assurance, Quality Control, Production, Planning, Purchasing, Marketing, Research & Development, Transfer) to investigation technical issues, implement process improvements, and complete validations. You will interact with external representatives on significant technical matters often requiring coordination between organizations/divisions. You will exercise independent judgement in developing methods, validation techniques, and evaluation criteria.
Responsibilities
- Performs investigational testing in the lab.
- Investigates unplanned deviations and non-conformances.
- Provides support for CAPA and root cause investigations.
- Creates Engineering Change Requests for document updates.
Requirements
- Bachelor's Degree in a Scientific field.
- 0-2 years experience in related industry.
- Previous lab experience. Prefer experience supporting manufacturing in a cGMP/FDA/ISO regulated industry.
- Understanding & knowledge of principles, theories, & concepts relevant to engineering and science.
- Problem-solving, organizational, analytical & critical thinking skills.
Benefits
- Competitive medical plans for you and your family
- Free HSA funds
- Fertility offering with stipend
- Group life and disability
- Paid parental leave
- 401k plus profit sharing
- Employee stock purchase program
- Upgraded mental health platform
- Extensive learning and development opportunities
- Education benefits
- Student debt relief program
- Pet insurance
- Wellness challenges and support
- Paid time off
- Employee Resource Groups (ERG's)
