Overview
On Site
Depends on Experience
Contract - W2
Contract - 12 Month(s)
Skills
manufacturing
Job Details
Job Title: Sr Manufacturing Engineer
Location: Santa Clara, CA
MUST HAVE: BioTech Industry Experience.
Job Description
Hands-on engineering role responsible for supporting critical Production and Development semi-automated equipment with troubleshooting (Root Cause Analysis), complex repairs, maintenance and calibration activities. This role acts as a subject matter expert in the care of semi-automated, custom production equipment, ensuring equipment remains operational at all times.
Responsibilities
- Lead / Support troubleshooting, repairs, maintenance and calibrations of semi-automated custom equipment.
- Perform Root Cause Analysis of equipment failures and identify Corrective and Preventative Actions.
- Perform Equipment Maintenance and Calibrations as required. Assist with defining and documenting Maintenance and Calibration requirements where required. Partner with external vendors as needed.
- Take an active role in identifying and implementing continuous improvements to increase operational efficiency of equipment.
- Support Equipment Qualifications and Validations, where necessary
Requirements
- BS/BA degree or equivalent in Engineering or Science required.
- 8+ years of relevant experience working in a regulated industry in roles related to Engineering or Operations.
- Experience in the Medical Device, Pharmaceutical, Biotechnology industries strongly preferred
- Experience working with electrical and mechanical (semi-automated / automated) equipment required
- Experience developing, executing, analyzing and documenting robust multivariate experiments (DOE) and statistical data analysis (using statistical software such as Minitab or JMP) is a plus.
- Process development and characterization experience is a plus.
- Experience working in a laboratory environment required; May be exposed to chemicals, including Hydrofloric Acid and other Buffered Oxide Etch solutions.
- Experience working in the semi-conductor manufacturing industry is a plus, but not required.
Hands-on engineering role responsible for supporting critical Production and Development semi-automated equipment with troubleshooting (Root Cause Analysis), complex repairs, maintenance and calibration activities. This role acts as a subject matter expert in the care of semi-automated, custom production equipment, ensuring equipment remains operational at all times.
Responsibilities
- Lead / Support troubleshooting, repairs, maintenance and calibrations of semi-automated custom equipment.
- Perform Root Cause Analysis of equipment failures and identify Corrective and Preventative Actions.
- Perform Equipment Maintenance and Calibrations as required. Assist with defining and documenting Maintenance and Calibration requirements where required. Partner with external vendors as needed.
- Take an active role in identifying and implementing continuous improvements to increase operational efficiency of equipment.
- Support Equipment Qualifications and Validations, where necessary
Requirements
- BS/BA degree or equivalent in Engineering or Science required.
- 8+ years of relevant experience working in a regulated industry in roles related to Engineering or Operations.
- Experience in the Medical Device, Pharmaceutical, Biotechnology industries strongly preferred
- Experience working with electrical and mechanical (semi-automated / automated) equipment required
- Experience developing, executing, analyzing and documenting robust multivariate experiments (DOE) and statistical data analysis (using statistical software such as Minitab or JMP) is a plus.
- Process development and characterization experience is a plus.
- Experience working in a laboratory environment required; May be exposed to chemicals, including Hydrofloric Acid and other Buffered Oxide Etch solutions.
- Experience working in the semi-conductor manufacturing industry is a plus, but not required.
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