- Responsible for building, cleaning, and packaging of various Single-Use assemblies per Engineering Process Records (EPR), drawings, and Standard Operating Procedures (SOP). - Wear appropriate personal protective equipment (PPEs) and report all near miss and first aid events. - Responsible for following cleanroom protocols and cGMPs in order to maintain ISO Class 7 environment. - Be an activate participant in the continuous improvement process and follow appropriate change control procedures. - Escalate potential process and/or product deviations to prevent scrap, rework, and customer returns. - Daily organization (6S) and cleanliness of work area and common areas. - Assist with the inventory accuracy by properly returning unused parts and components to stock in sealed bags with part number and lot traceability.- Participate and work within quality standards guidelines in all manufacturing areas in accordance with company quality goals. - Meet internal manufacturing schedules which drive on-time delivery. - Complete and sign-off EPRs for each operation completed during the assembly. - Complete assemblies within the allotted time stated on the work order. - Instill a build it right the first time mentality. - Performs other duties as assigned.
1-4 years
- Experience working in a cleanroom environment - Experience interpreting engineering drawings - Knowledge of Lean manufacturing - Knowledge, Skills, & Abilities: - Strong communication skills - Ability to work in a team environment - Perform duties with the highest regard for safety and quality - Ability to be trained on and adhere to all cleanroom protocols - Ability to understand and follow site protocols, policies and procedures- Must be flexible, forward- thinking, motivated, and have the ability to act independently - Must be able to lift 50lbs minimum - Basic computer skills including Microsoft Office with proficiency in Word and Excel - Problem-solving skills
- Working knowledge of cGMP- Manufacturing experience- Cleanroom experience
High School
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