Cleanroom Operator I

Thermo Fisher Scientific•Miami, OK

1d•Onsite

About The Position

As part of Thermo Fisher Scientific’s Single Use Division, the Cleanroom Operator I supports critical manufacturing operations at the company’s Miami, Oklahoma location. The role involves operating production equipment, executing manufacturing processes, and maintaining compliance with quality, safety, and regulatory requirements. The operator performs equipment operation, production documentation, and routine manufacturing activities while following established procedures and developing technical skills. Through teamwork, continuous learning, and Right First Time execution, the role supports operational performance, product quality, and customer satisfaction. The position is fully onsite in a temperature-controlled cleanroom. Work includes operating critical-environment processing equipment and carrying out manufacturing activities such as washing, drying, depyrogenation, sealing, packaging, product sampling, archive management, and final packaging. The operator maintains accurate records, performs certified area cleaning, reports process or safety concerns, and follows applicable procedures and safety requirements. A 10-hour day shift is listed; overtime may be required.

Requirements

High school diploma or equivalent.
Ability to safely operate designated production equipment and follow established procedures.
Ability to perform packaging, sampling, archive management, and production documentation while meeting 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 the ability to meet production standards and adapt to changing priorities.
Strong communication and teamwork skills, willingness to accept constructive feedback, and willingness to learn and develop new skills.
Adherence to GMP and safety standards and cleanroom restrictions.
Ability to work in a fast-paced environment and perform the physical requirements of the role, including standing, walking, reaching, bending, twisting, stooping, pushing, pulling, forceful gripping, repetitive hand movements, and lifting up to 50 pounds unassisted.
Ability to use required personal protective equipment and work around loud equipment and machinery.

Nice To Haves

Previous experience in cGMP manufacturing, production, operations, warehousing, or a regulated manufacturing environment.

Responsibilities

Operate designated critical-environment equipment, including WFI wash systems, dryers, depyrogenation equipment, sealers, and packaging equipment, in accordance with established procedures and safety requirements.
Execute washing, drying, depyrogenation, sealing, packaging, product sampling, archive management, and final packaging processes 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.