Cleanroom Operator I

Thermo Fisher Scientific•Miami, OK

1d•Onsite

About The Position

The Cleanroom Operator I supports critical manufacturing operations in Thermo Fisher Scientific’s Single Use Division at its Miami, Oklahoma location. The role operates production equipment, executes manufacturing processes, and maintains compliance with quality, safety, and regulatory requirements. It includes equipment operation, production documentation, and routine manufacturing activities performed according to established procedures, with opportunities to develop technical skills. The position contributes to operational performance, product quality, and customer satisfaction through teamwork, continuous learning, and Right First Time execution. This is a fully onsite, second-shift role based in a temperature-controlled cleanroom. The work requires adherence to GMP and safety standards, cleanroom restrictions, and PPE requirements. The operator may need to work additional overtime and perform physical activities throughout the shift, including standing, walking, reaching, bending, and lifting.

Requirements

High school diploma or equivalent.
No previous work experience required.
Basic knowledge of critical-environment manufacturing processes and ability to safely operate designated production equipment while following procedures.
Ability to perform packaging, sampling, archive management, and production documentation to quality and production standards.
Ability to read, comprehend, and follow SOPs, WOIs, JSAs, Plant Safety Rules, and other manufacturing documentation.
Basic understanding of operational KPIs, event recognition, 7-S principles, and safe manufacturing practices.
Effective time-management and organizational skills, including ability to meet production standards and adapt to changing priorities.
Strong communication and teamwork skills; ability to accept constructive feedback and willingness to learn and develop skills.
Ability to adhere to GMP and safety standards and cleanroom requirements.
Ability to work in a fast-paced environment and work additional overtime as required.
Ability to safely perform physical requirements including standing, walking, reaching, bending, twisting, stooping, pushing, pulling, forceful gripping, repetitive hand movements, and lifting up to 50 pounds unassisted.
Ability to comply with cleanroom restrictions on personal products and items, including hair products, jewelry, makeup, nail polish, acrylic nails, perfume or cologne, exposed piercings, lip balm, lotion, and chewing gum.
Ability to use required PPE, including safety-toed boots, high-visibility gear, safety glasses, cleanroom suit, hair and beard coverings, gloves, lab coat, and ear plugs.

Nice To Haves

Previous experience in cGMP manufacturing, production, operations, warehouse, or another regulated manufacturing environment.

Responsibilities

Operate designated critical-environment processing equipment, including WFI wash systems, dryers, depyrogenation equipment, sealers, and packaging equipment, following procedures and safety requirements.
Execute manufacturing processes including washing, drying, depyrogenation, sealing, packaging, product sampling, archive management, and final packaging while meeting production schedules and quality standards.
Maintain accurate production documentation, including SOPs, Work Instruction Outlines (WOIs), labels, and critical-environment records, in compliance with cGMP and quality requirements.
Perform certified area cleaning activities and maintain cleanroom standards.
Recognize and report process events, quality concerns, and safety issues.
Follow SOPs, WOIs, JSAs, Plant Safety Rules, and cleanroom procedures.
Follow production standards, understand operational KPIs, and participate in 7-S workplace organization activities.
Collaborate with team members, accept constructive feedback, demonstrate flexibility to support production schedules, and perform other assigned duties.