The Pharmaceutical 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.
• Operate, maintain, assemble & disassemble, clean and set-up applicable production equipment.
• Execute batch records and production of material promptly and with the highest quality standards.
• Maintain documentation and functional work areas to GMP standards.
• Capable of lifting and moving heavy equipment parts and containers.
Training or Experience:
• Must possess mechanical aptitude.
• Must be familiar with computer applications.
• Must possess knowledge of the metric weight system.
• Must be able to adhere to outlined procedures and practices and follow specific instructions.
• Must possess strong math skills, documentation skills, and organization skills.
• Must be able to lift up to 40-50 lbs.
• Must possess good manual dexterity.
• Must possess basic knowledge of cGMP’s.
• Must be able to transcribe detailed data accurately according to GMP and SOP standards.
• Must be able to work overtime with little or no notice. Must maintain good attendance.
• Responsible for maintaining the company’s high standards of quality, to meet the day-to-day scheduling needs and have the ability to accomplish the departmental goals
High School Diploma/Associate Degree preferred
3 – 5 Years experience in cGMP/Aseptic Operations Background