Job Description

Job Title

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.

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