Job TitleJob 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. ResponsibilitiesLead / 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 necessaryRequirementsBS/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 preferredExperience working with electrical and mechanical (semi-automated / automated) equipment requiredExperience 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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