Wash and Sterilization Technician I

Role Summary

Wash, sterilize, unload & assemble components & equipment in an aseptic environment. Supply Filling & Formulation teams at the right rate, the right time & consistent with business/regulatory needs.

Responsibilities

• Perform aseptic activities including, but not limited to, processing components, parts & assemblies, troubleshooting equipment, aiding in setup & teardown of equipment
• Clean, prepare, wrap, assemble & sterilize production components & parts
• Check & adjust mechanical assemblies critical to the accurate & aseptic filling of insulin
• Inspect & process components necessary for the formulation of insulin within an aseptic environment
• Operate, monitor & control equipment, systems & processes
• Achieve production goals
• Cross train & become proficient in the setup & operation of all filling operations
• Maintain aseptic areas & perform sanitizations & environmental monitoring
• Participate actively in & support event response
• Review, revise & author SOP‚Äôs & other documents as required
• Assist during equipment maintenance including restoration of lost function, predictive & preventative maintenance
• Record/review production data in BPR & associated forms
• Follow all safety & environmental requirements in the performance of duties
• Other accountabilities, as assigned

Qualifications

• Required: High school diploma or equivalent
• Required: Minimum of six (6) months manufacturing experience
• Preferred: Experience working in an FDA regulated environment
• Preferred: Aseptic processing experience
• Required: Ability to read, write & understand complicated product documentation & standard operating procedures with attention to detail
• Preferred: Computer literacy

Additional Requirements

• Physical requirements: Moves equipment and/or supplies weighing up to 33 pounds, on your feet for up to a 12-hour shift, potential use of ladders, work in cold or hazardous environments, use protective equipment as required