- 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 ISO 9001:2015 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 interpreting engineering drawings- Knowledge of Lean manufacturing- 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
- 1-2 years equivalent experience in production in a cleanroom environment- High School completion or equivalent (GED)
High School
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