Cleanroom Operator I

Thermo Fisher Scientific•Miami, OK

4d•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, completing production documentation, and maintaining compliance with quality, safety, and regulatory requirements. The operator follows established procedures while developing technical skills and contributing to operational performance, product quality, and customer satisfaction through teamwork, continuous learning, and Right First Time execution. The role is fully on-site in a temperature-controlled cleanroom. Cleanroom restrictions prohibit items and products such as hair products, jewelry, makeup, nail polish, acrylic nails, perfume or cologne, exposed piercings, lip balm, lotion, and chewing gum. Required personal protective equipment may include safety-toed boots, high-visibility gear, safety glasses, a cleanroom suit, hair and beard coverings, gloves, a lab coat, and ear plugs. The work can involve loud machinery, standing and walking for extended periods, and additional overtime as required. Employees must follow GMP and safety standards and be able to perform the role’s physical tasks, including lifting up to 50 pounds without assistance.

Requirements

High school diploma or equivalent.
Ability to safely operate designated production equipment while following established procedures.
Ability to perform packaging, sampling, archive management, and production documentation to applicable quality and production standards.
Ability to read, understand, 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; ability to accept constructive feedback and willingness to learn and develop new skills.
Ability to work in a fast-paced environment and work additional overtime as required.
Ability to 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 comply with GMP, safety standards, cleanroom restrictions, and required PPE practices.

Nice To Haves

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

Responsibilities

Operate designated critical-environment processing equipment, including WFI wash systems, dryers, depyrogenation equipment, sealers, and packaging equipment, according to established procedures and safety requirements.
Carry out washing, drying, depyrogenation, sealing, packaging, product sampling, archive management, and final packaging while meeting production schedules and quality standards.
Complete and maintain accurate production documentation, including SOPs, Work Instruction Outlines (WOIs), labels, and critical-environment records.
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, cleanroom procedures, and applicable quality and safety requirements.
Follow established production standards, understand operational KPIs, and participate in 7-S workplace organization activities.
Work collaboratively with team members, accept constructive feedback, adapt to production schedules, and perform other assigned duties supporting manufacturing and business operations.