We are looking for a Sterile Manufacturing Technician to join the growing Phase III team. The incumbent will be responsible for the manufacturing of sterile liquids for commercial distribution and clinical trials.
The Sterile Manufacturing Technician, Blow Fill Seal will be responsible for the set-up, operation and cleaning of all pharmaceutical manufacturing/packaging equipment including; Rommelag Blow Fill Seal machine, sterilizer and labeling equipment.
Personnel in this position will operate 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 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.
- Follow written procedures.
- Provide assistance to other operators.
- Clearly and accurately document activities.
- Perform basic math calculations.
- Perform in-process weight checks and component counting.
- Submit in-process samples to the analytical and microbiology labs.
- Perform 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 specifications.
- Attain and maintain Aseptic Gown Certification.
- Collect samples from controlled areas and systems such as compressed gases and water.
- Operate appropriate monitoring sampling and testing equipment.
- Prepare supplies required for collecting and testing of samples.
- Write clear concise observational memo and assist in investigation of controlled areas.
- Operate Autoclave to prepare/sterilize supplies as needed.
- Read, understand and review SOP’s and Protocols as required.
- Review environmental data; verify all monitoring plates are received from controlled areas prior to incubation of monitoring plates into appropriate incubators.
- Enter or verify environmental data into database.
- High School Diploma/Associate Degree preferred
- 3 – 5 Years of experience in cGMP/Aseptic Operations Background