Cleanroom Technician (Fill) - 3rd Shift

About the job

The Cleanroom Fill Technician will assemble finished sterile products with a focus on patient safety and quality; ensures 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 clean room 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.
• Takes inventory in the clean room to identify components needed to fill production batches, as scheduled.
• Safeguards all components entering the clean room are sterile.
• Collaborates and communicates with compounding and vial wash to obtain supplies needed to turn products; communicates within the clean room, 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.
• Designates people and hoods for different tasks.
• Uses appropriate process to establish sterility on products received via pass through from compounding.
• Clocks in and out for every scheduled shift in a timely manner.

Basic Qualifications

• A high school diploma or equivalent;
• One to four years previous work experience in a hospital or manufacturing environment or doing aseptic filling;
• Knowledge of clean room procedures, preferred but not required;
• Knowledge of and compliance with CGMP (Current Good Manufacturing Practices) regulations, preferred but not required;
• Must pass validation three consecutive times before handling product in clean room; must be re-qualified every 6 months with a minimum requirement of filling a set minimum of syringes and vials in an established time frame and difficult operation conditions.

Preferred but not required

• Ability to work with others in a positive and professional manner and to develop and maintain strong working relationships with co-workers and management.
• Ability to take initiative, including asking for and offering help when needed; performs work independently without being prompted.
• Strong attention to detail and focus on quality, accuracy, sterility, and aseptic technique.
• Ability to prioritize and plan work activities.
• Manages time effectively and adapts quickly to changing priorities.
• Ability to handle multiple tasks and organize resources to ensure work is completed on time.

What's on Offer?

• We offer a dynamic environment where talent and ambition can develop to its fullest.
• We have an open and informal organization culture, where individuals need to have strong motivation and ability to work independently.
• Fagron is a widely expanding, international, professional and ambitious pharmaceutical company with multiple growth opportunities.
• Job opportunity includes competitive salary, comprehensive benefits, performance package, and ability to be part of an international leader in an expanding industry.