CLEAN ROOM OPERATOR

Description:

SUMMARY

The cleanroom operator is responsible for assembling, testing, inspecting, and packaging medical devices per work instructions using a variety of assembly equipment, fixtures and test equipment. Technician works on assignments that are semi-routine in nature, where the ability to recognize deviation from accepted practice is required.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. 

• Assemble subassemblies or finished parts using fixtures, hand presses and manufacturing equipment accordingly.
• Visually inspect parts throughout job run for defects. Use measurement tools such as a ruler, measuring tape, calipers, or micrometers to check dimensions.
• If out of specifications, make necessary adjustments to correct problem. If necessary, consult with Production Supervisor.
• Manufacture components accordingly to Standard Operations Procedures (SOP) and thru training provided by the Quality and the Manufacturing Department.
• Read blueprint or job order for product specifications and determine sequence of operations.
• Preform the assembly of products using plastic tubes, tubing, fittings, and components under moderate supervision and with some latitude for independent judgement
• Technician will be cross trained on all operations involved in the manufacturing process inside and outside of the clean room.
• Follows cleanroom policies to limit the 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 of 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.

Teamwork is essential for WHK’s continued success, so Teamwork is an essential function of every employee’s job. Teamwork drives positive results every day. Teamwork promotes positive customer relations and results in exceeding the expectations of our customers. Teamwork benefits every employee since it grows our business and increases our sales. With Teamwork, we all succeed. Without it, we all suffer. Teamwork with coworkers in the same department is just the beginning. Teamwork with every other employee, department and division is the Teamwork that is required to succeed. WE ARE WHK.

Requirements:

SAFETY TRAINING 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”.

QUALIFICATIONS To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION AND/OR EXPERIENCE
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.

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.

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.

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.

PHYSICAL DEMANDS 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.

WORK ENVIRONMEN T 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.

PI4e65c6d3ddb9-37456-41041835