Summary:
The EO Operator leads the sterilization process to ensure the quality processing of products for shipment.
Key Duties and Responsibilities:
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Operates the sterilization process and ancillary equipment.
- Moves materials through all steps of the sterilization process.
- Ensures compliance with established safety policies and procedures.
- Creates work orders, assigns, and returns materials as necessary to ensure quality and inventory control.
- Inspects machines and equipment to ensure specific operational performance and optimum utilization, creating work orders for the maintenance department in a timely manner.
- Maintains general housekeeping for assigned production areas within cGMP guidelines.
- Alerts Team Lead of any foreseen or unforeseen conflicts that may arise with the production schedule.
- Ensures all documentation information is recorded according to Good Documentation Practices.
- Communicates any opportunities for improvement in processes and documentation to the Team Lead.
- Maintains organization of current inventory.
- Collaborates closely and harmoniously with the Quality Assurance team and upper management to ensure a friendly environment where end-user satisfaction, product quality, and company integrity are always prioritized.
- Performs other duties as assigned.
Qualifications, Education, and/or Experience Required:
- Self-motivated, with the ability to perform well both independently and as part of a team; capable of identifying risks and proposing solutions.
- Able to handle multiple priorities and meet tight deadlines.
- Detail-oriented, with strong problem-solving, critical thinking, and communication skills (both verbal and written).
- Two to five years of experience in the medical devices or FDA-regulated industry (manufacturing/production) is highly desirable.
- Computer literacy is required.
- Knowledge of cGMP, FDA requirements, and ISO standards is a plus.
- Minimum high school diploma or GED equivalent; some technical or college education is preferred.
- Must be able to work "off" hours with minimal supervision, as required.
Language Skills:
- English is required; bilingual (Spanish) skills are a plus.
Physical Demands:
- The position requires walking and standing for prolonged periods and may occasionally involve sitting, climbing, balancing, stooping, kneeling, crouching, or crawling.
- Frequently lifts and/or moves up to 10 pounds; occasionally lifts and/or moves up to 50 pounds.
- Must be free of any health condition that would prohibit assignments to an ethylene oxide-related area.
Work Environment:
- Non-temperature-controlled warehouse and production floor; temperature-controlled office.
AAP/EEO Statement:
CHEMENCE® provides equal employment opportunities to all employees and applicants, prohibiting discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability, genetics, veteran status, sexual orientation, gender identity, or any other characteristic protected by federal, state, or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
