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Sterile Production Technician
2 months ago
The Sterile Production Technician plays a crucial role in assembling finished sterile products, prioritizing patient safety and quality assurance. This position ensures that the cleanroom environment is consistently maintained in a state of cleanliness and that all supplies are properly organized.
Key Responsibilities:
- Uphold a sterile environment within the cleanroom by adhering to proper garbing, cleaning protocols, and following cleanroom procedures in accordance with CGMP standards.
- Conduct daily cleaning of equipment within the cleanroom and verify that all equipment validations are current.
- Implement the "tech check tech" process to supervise the techniques and practices of team members, including product assembly, measurements, garbing, sterile techniques, and documentation.
- Manage inventory within the cleanroom to determine necessary components for scheduled production batches, ensuring all items entering the cleanroom are sterile.
- Facilitate communication with compounding and vial wash teams to procure essential supplies for product preparation.
- Maintain accurate documentation of batch records, environmental measurements, equipment maintenance logs, and cleaning records.
- Prepare and sterilize components and solutions for filling into designated containers, ensuring compliance with established protocols.
- Conduct semi-annual validations to confirm adherence to garbing standards.
- Successfully complete three consecutive media fills with a predetermined minimum of syringes and vials as established by the quality department.
- Follow standard operating procedures for packaging sterile products in their final container closures, designating specific personnel and equipment for various tasks.
- Clock in and out punctually for each scheduled shift.
Qualifications:
Applicants should possess a high school diploma or equivalent, with one to four years of relevant experience in a hospital or manufacturing setting, particularly in aseptic filling.
Knowledge of cleanroom protocols and CGMP regulations is preferred but not mandatory.
Candidates must successfully pass validation three consecutive times before handling products in the cleanroom and undergo re-qualification every six months, meeting the minimum filling requirements.
Strong interpersonal skills are essential for fostering positive working relationships with colleagues and management. Candidates should demonstrate initiative, the ability to work independently, and a keen attention to detail, ensuring quality, accuracy, and sterility in all tasks.
Effective time management and adaptability to changing priorities are crucial, along with the ability to handle multiple tasks and organize resources efficiently.
What We Offer:
Fagron Sterile Services provides a dynamic work environment that fosters talent and ambition. Our organizational culture is open and informal, encouraging individuals to demonstrate strong motivation and the ability to work autonomously.
As a rapidly expanding international pharmaceutical company, we offer numerous growth opportunities, competitive salaries, comprehensive benefits, and a performance package, allowing you to be part of a leader in an evolving industry.
