Clean Room Operator

4 weeks ago

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

We are seeking a highly skilled Clean Room Operator to join our team at T S E INDUSTRIES INC. in a dynamic and fast-paced environment.

Job Summary

The Clean Room Operator will be responsible for assembling, testing, inspecting, and packaging medical devices in a cleanroom environment. This role requires attention to detail, strong organizational skills, and the ability to work independently with minimal supervision.

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.
  • Technician will 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.
  • Responsible for coordinating and cooperating 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

To perform this job successfully, an individual must complete and maintain the following Safety Training requirements:

  • General Safety Orientation
  • CD-ROM course tailored to specific individual requirements within their job Training Suite

Additionally, the individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required:

  • 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.

The individual must also be able to read and comprehend simple instructions, short correspondence, and memos, and be able to write simple correspondence. Additionally, the individual must be able to effectively present information in one-on-one and small group situations to customers, clients, and other employees of the organization.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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.

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.

The noise level in the work environment is usually very quiet.

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