Cleanroom, Consulting, Detail Oriented, Documentation, High School Diploma, Housekeeping/Cleaning, Identify Issues, Inventory Management, Machine Tool, Manufacturing, Manufacturing Operations, Medical Equipment, Microsoft Excel, Microsoft Office, Operational Support, Printers, Process Improvement, Production Systems, Quality Management, Record Keeping, Regulations, Regulatory Compliance, Safety/Work Safety, Technical Support, Traceability
Position Summary
We are seeking a Contract to Hire Cleanroom Operations Associate. The Cleanroom Operations Associate supports manufacturing operations in a regulated medical device environment. This role ensures product integrity, traceability, accurate documentation, and regulatory compliance while operating equipment, assembling products, and maintaining cleanroom standards.
Responsibilities
- Perform routine cleaning, maintenance, and monitoring of cleanroom and controlled areas
- Operate automated machinery, measurement tools, label printers, and related equipment
- Assemble and package medical devices
- Assist with shutdowns and operational events
- Support engineering with troubleshooting and process improvements
- Maintain product integrity and traceability through accurate documentation of Manufacturing Orders
- Complete and maintain regulatory batch records
- Follow Quality Management System (QMS) requirements
- Maintain a safe work environment in a regulated setting
- Assist with cleanroom inventory control
Requirements
- Detail-oriented and able to follow structured procedures and work instructions
- Able to work independently with minimal supervision
- Proficient in Microsoft Office (Excel required)
- Comfortable working in a cleanroom environment with required garments and PPE
- High School Diploma or equivalent
- 2+ years in production or manufacturing environment preferred
- Medical device manufacturing experience preferred
- Cleanroom experience preferred
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