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Assembler in Cleanroom / Controlled Enviroment

Assemble single-use kits containing tubing, connectors, filters and various component parts in a cleanroom environment while wearing full PPE (Personal Protective Equipment, full jumpsuit, headcovering, goggles and gloves). Must be able to recognize items from drawings, Bill of Materials and/or Job Travelers. Set up and Operate kit assembly equipment according to safe operating procedures as required including tube cutting, heat sealing, ultra sonic welding. Complete kits according to work instructions and within production schedule. Follow procedures for entering/exiting work area, putting on appropriate PPE to work in ISO 7 cleanroom. Keep records according to GDocP for lot number traceability and completion of work order.

Representative Responsibilities:

Understand and follow protocol for entering/exiting work area, bringing materials in/taking finished product out of work area, assembling product by an established work instruction/protocol, testing product, packaging and labeling. Responsible for self-inspection of work. Understands identifying and segregating nonconforming materials and/or product.

Understand and follow work instructions, drawings and specifications for each product being assembled. Ability to read a Job Traveler for key information including Job Number, Bill of Materials (correct product identification, quantity and lot #), Operations to be performed, Inspection and Quality criteria, Quantity of product to be completed and Required By Date.

Ability to set up and operate various kit assembly equipment in a safe manner including (but not limited to) ultra-sonic welder, tubing cutter, inserter as required for each product. As appropriate, perform scheduled cleaning operations and preventative maintenance actions on equipment in a timely manner.

Skills, Knowledge, Qualifications & Experience:

Education: High School diploma or equivalent required. Ability to read and comprehend English. Legible handwriting required. Knowledge of ISO 9001 Quality Management systems preferred, on the job training required.

Experience: Manual dexterity and persistence to assemble small components for two 4-hr. shifts to meet production goals. Ability to use small tools effectively to assemble components. Ability to read and understand drawings, work instructions, Job Traveler and follow written and verbal directions in order to assemble product to meet quality criteria. Corrected 20/20 eyesight with the ability to visually inspect product for small visible particulate to meet quality criteria. A minimum of 2 years experience in related product manufacturing with a proven record of high first time yield, quality training and self-inspection of work a strong plus. Knowledge of 5S and/or Lean principles and practices in the manufacturing process highly desirable.

Comments:

This position requires: attention to detail, concentration to assemble kits to meet quality criteria over two 4 hour shifts with break in between. Consistent, repeatable results to meet production requirements, a positive attitude and desire to achieve results in a team environment, a desire for continual learning and the ability to identify, suggest and implement improvements into processes.

Cleanroom employees will be trained and are required to demonstrate the ability to work in a clean room environment. They will also be trained and must demonstrate the ability to keep appropriate records that evidence work protocols are followed.

Cleanroom Personal hygiene requirements include no perfume/cologne, jewelry, or make up allowed in the cleanroom. No smoking within 1 hour of entering the cleanroom. Employees with skin lesions, abrasions, open wounds, or newly applied skin art are not eligible for shift work in the cleanroom. No employee-owned cell phones allowed in the cleanroom.

Intellitech, Inc. designs and manufactures the family of i-FILL precision dispensing pumps and single-use systems (see our website www.intellitech-inc.com) for the life science industry in a controlled environment per a ISO 9001 Quality Management System.
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