Cleanroom Fill Technician (Mon-Thurs 3:30p-2a)

About The Job The Cleanroom Fill Technician will assemble finished sterile products with a focus on patient safety and quality; ensure that the clean room remains in a state of constant cleanliness and that supplies are appropriately stacked. Key Responsibilities Maintains a sterile environment in the cleanroom, by garbing, cleaning the room, and behaving according to clean room procedures that align with CGMP practices or guidelines. Cleans the equipment in the cleanroom daily; ensures equipment validations are up to date. Follows the “tech check tech” process to oversee the techniques and practices of co-workers, including product assembly, measurements, garbing, sterile techniques, and documentation. Take inventory into the cleanroom to identify components needed to fill production batches, as scheduled. Ensure all components entering the clean room are sterile. Coordinates and communicates with compounding and vial wash to obtain supplies needed to turn products; communicates within the cleanroom, from room to room. Documents batch records, Climents (measurements of air in the room), lumacs (log use, maintenance, and cleaning of all equipment), and cleaning logs. Prepares and sterilizes components/vials for appropriate solutions; sterilizes solutions and fills into specified containers. Validates that garbing standards have been followed on a semi-annual basis. Completes 3 consecutive media fills with a set minimum of syringes and vials that is established by the quality department in an established time frame and in the most difficult operating conditions to pass validation every 6 months. Follows standard operation procedures to package sterile products in their final container closure. Designate people and hoods for different tasks. Use appropriate process to establish sterility on products received via pass through from compounding. Basic Qualifications High school diploma or equivalent required; 1+ year of experience in healthcare, manufacturing, or a similar regulated environment preferred. Familiarity with cleanroom procedures and cGMP requirements preferred. Strong attention to detail with a focus on quality, accuracy, sterility, and aseptic technique. Ability to follow established procedures, prioritize tasks, manage time effectively, and adapt to changing priorities. Ability to work independently and collaboratively while maintaining positive, professional relationships with coworkers and management. Must successfully complete required cleanroom, gowning, and aseptic technique qualification before handling product and maintain qualification through required periodic requalification. Working Conditions This position requires standing and walking for extended periods of time, including time spent in compounding, production, and controlled environments. Sitting, walking, bending, and reaching may be required throughout the workday. The employee will routinely enter and work within controlled areas, including cleanrooms and other designated compounding and production spaces. The employee will be required to follow established hand hygiene, garbing, gowning, and entry procedures when entering controlled environments. Appropriate personal protective equipment (PPE) is required based on the work area and assigned activities. The employee may be exposed to pharmaceutical ingredients, cleaning agents, disinfectants, chemical odors, and other materials used in compounding and facility operations. The employee may be required to work around active compounding, filling, packaging, and production equipment. Work may be performed in areas with moderate to high noise levels from equipment, machinery, and surrounding personnel. The employee may occasionally be required to lift and/or move materials, supplies, or equipment weighing up to 40 pounds. Team lifting is encouraged when appropriate. What's on Offer? Fagron offers its associates competitive salaries and a wide range of benefits including a 401(k) plan with a company matching contribution; medical, vision and dental; health savings account (HSA); holiday/paid time off. At Fagron, you’ll find plenty of chances to grow — both personally and professionally. We work in an open, dynamic environment where your ideas and talents can shine. Ready For The Challenge? We’re proud to be an equal opportunity employer. Diversity makes us stronger, and we’re committed to creating an inclusive workplace where everyone feels welcome. Fagron US is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. #J-18808-Ljbffr Fagron Nederland BV