Cleanroom Operations Specialist
Corporate Statement
Nephron Nitrile is a new privately-owned Nitrile Glove manufacturer. Nephron Nitrile products are proudly made in the USA! We are headquartered in West Columbia, South Carolina. The facility utilizes completely automated manufacturing, packaging, and distribution systems, in addition to high volume and redundant utility systems, to ensure production system availability.
Position Purpose
The Cleanroom Operations Specialist is responsible for the day-to-day execution and oversight of ISO 7 cleanroom operations used for the cleaning and drying of polyurethane and nitrile gloves to create gloves that can be used in cleanroom environments. This role ensures safe, compliant, and efficient operation while maintaining alignment with ISO 13485 quality management system requirements. The Specialist acts as the operational focal point between Research, Quality, and Engineering and may directly operate equipment as required by workload. Ultimately, this position will transition to Production once stable operation is established. This transition is expected to occur within 180 days.
Key Responsibilities
· Plan and coordinate daily cleanroom activities, including washer and dryer scheduling
· Monitor clean water availability and coordinate with facilities or engineering as needed
· Ensure adherence to ISO 7 cleanroom practices, gowning, and contamination control
· Track daily throughput (gloves cleaned per shift) and cleanliness performance metrics
· Perform or support the operation of BWE BW2120 washers and GZ-D Z-100 HEPA dryers when required
· Perform or support the operation of the Zebra printer and the ACCVACC vacuum sealer
· Ensure equipment is operated per validated parameters and approved work instructions
· Identify operational deviations and escalate per CAPA and nonconformance procedures
· Support internal audits, inspections, and management reviews as required
· Train and mentor cleanroom operators on SOPs and GMP behaviors
· Coordinate with Quality to ensure release criteria and documentation completeness
Qualifications and Experience
· Associate’s or Bachelor’s degree in science, engineering, or manufacturing preferred
· Minimum 3–5 years of experience in cleanroom, medical device, or regulated manufacturing
· Demonstrated knowledge of ISO 13485 and GMP principles
· Experience operating or supervising industrial washing and drying equipment preferred
· Strong documentation, communication, and organizational skills
EEO Statement:
Nephron Nitrile is an equal employment opportunity employer and does not discriminate against employees or job applicants on the basis of race, religion, color, sex, sexual orientation, age, national origin, mental or physical disability of a qualified individual, veteran or military status, pregnancy, marital status, familial status, genetic information, or any other consideration made unlawful by applicable federal, state or local law.
Nephron Nitrile is a drug free workplace.