Clean Room Assembly Technician

2 weeks ago

Clearwater, United States T S E INDUSTRIES INC. Full time
Clean Room Operator Job Summary

We are seeking a highly skilled Clean Room Operator to join our team at T S E INDUSTRIES INC. The successful candidate will be responsible for assembling, testing, inspecting, and packaging medical devices in a cleanroom environment.

Key Responsibilities:
  • Assemble subassemblies or finished parts using fixtures, hand presses, and manufacturing equipment.
  • Visually inspect parts throughout the job run for defects and use measurement tools to check dimensions.
  • Make necessary adjustments to correct problems and consult with the Production Supervisor if needed.
  • Manufacture components according to Standard Operations Procedures (SOP) and training provided by the Quality and Manufacturing Department.
  • Read blueprint or job order for product specifications and determine the sequence of operations.
  • Perform the assembly of products using plastic tubes, tubing, fittings, and components under moderate supervision.
  • Be cross-trained on all operations involved in the manufacturing process inside and outside of the clean room.
  • Follow cleanroom policies to limit airborne particles and bioburden in the cleanroom environment.
  • Coordinate and cooperate in a team production environment to ensure products are produced orderly, efficiently, and with the highest quality.
  • Utilize Epicor MES software during the manufacturing process based on the travelers.
  • Report problems with quality, processes, equipment, or materials to the Production Supervisor.
  • Complete line clearance, scrap records, training records, and other documentation as required.
  • Support housekeeping activities.
  • Perform other duties as required.
Requirements:
  • Clean Room Operator Safety Training: Complete and maintain General Safety Orientation and CD-ROM course tailored to specific individual requirements within their job Training Suite.
  • Clean Room Operator Qualifications: High school diploma or general education degree (GED) preferred; or one to three years related experience or training; or equivalent combination of education and experience in working in a clean room environment. GMP/ISO awareness as they apply to medical/pharmaceutical manufacturing.
  • Clean Room Operator Language Skills: Ability to read and comprehend simple instructions, short correspondence, and memos. Ability to write simple correspondence. Ability to effectively present information in one-on-one and small group situations to customers, clients, and other employees of the organization.
  • Clean Room Operator Mathematical Skills: Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent, and to draw and interpret bar graphs.
  • Clean Room Operator Reasoning Ability: Ability to apply common sense understanding to carry out detailed but uninvolved written or oral instructions. Ability to deal with problems involving a few concrete variables in standardized situations.
  • Clean Room Operator Physical Demands: Work in a clean room environment. While performing the duties of this job, the employee is regularly required to stand; use hands to finger, handle, or feel, and reach with hands and arms. The employee frequently is required to talk or hear. The employee is occasionally required to walk; sit; climb or balance; stoop, kneel, crouch, or crawl; and taste or smell. The employee must regularly lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, depth perception, and ability to adjust focus.
  • Clean Room Operator Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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