Sterile Manufacturing Technician

Sterile Manufacturing Technician

A Sterile Manufacturing Technician is responsible for the manufacturing of sterile liquids for commercial distribution and clinical trials. Personnel in this position will support the production operation by handling aseptic cleaning and specializing in more than one of the processing areas (cleaning, formulation, aseptic filling, equipment preparation, terminal sterilization, etc). This includes but is not limited to operating manufacturing processing equipment by following standard operating procedures and batch records in accordance with FDA current Good Manufacturing Practices. In addition, personnel in this position will employ above average mechanical aptitude and acceptable aseptic techniques while working in controlled and classified environments, some of which require complete aseptic gowning. Personnel in this position will provide support in inspection and packaging areas as required.

Responsibilities :

• Troubleshoots a majority of basic machine issues and reaches out for maintenance support when needed in order to meet production timelines.
• Serves as setup mechanic for all area specific filling equipment.
• Has mastery of multiple aseptic processing concepts and steps including aseptic cleaning, equipment preparation for sterilization, product pathway assembly, sterile filtration, aseptic filling and terminal sterilization.
• Possesses competitive, detailed oriented production mentality and is not satisfied by anything less than perfection.
• Provides training to other operators.
• Follows written procedures.
• Clearly and accurately document activities in batch records and logbooks.
• Performs basic math calculations.
• Performs in-process weight checks and component counting.
• Submits in-process samples to responsible departments.
• Performs cleaning of rooms, tools and equipment.
• Performs specific visual inspections based on clearly outlined checks and specifications for the finished product.
• Responsible to ensure that the product meets specification.
• Maintain Aseptic Gown Certification.
• Operate Autoclave to prepare / sterilize supplies as needed.
• Read, understand and review SOP's and Protocols as required.

Job Responsibilities :

Qualifications :

Education :

High School Diploma / Associate Degree preferred.

Experience :

2 4 Years experience in CGMP / Aseptic Operations Background.