Fermentation: March 2018-December 2024
Grow Bacteria following Manufacturing Directions from start to harvest. Includes starting and passing seed in clean rooms to growing seed vessels and production vessels along with inactivation of the Bacteria. Perform downstream processing which may include concentrations, homogenization, and centrifugation. This involves working with stationary and portable equipment and steam.
Position Responsibilities
- Execution of aseptic techniques and clean room procedures or support area procedures in a GMP facility.
- Maintain and edit, as appropriate, departmental cGMP documentation.
- Execute and lead operation to comply with all written procedures, to include Batch Records and SOPs.
- Follow and comply with all financial procedures.
- Follow and comply with all site safety procedures. Identify ways to improve the safety culture of the department.
- Operation of departmental equipment to include set up and take down. Provide oversight as necessary.
- Effectively work in a team environment and communicate with multiple departments.
- Follow good GMP practices.
- Clean room gowning required.
- Perform Aseptic processing skills while working in a clean room setting.
- Preventive Maintenance of Seed and Production Vessels.
- Maintain accurate inventory.
- Follow Manufacturing Directions.
- Mentor / train colleagues as needed.
Provide department oversight as requested including shift change, schedule changes etc.
TCO (Tissue Culture Origin) : October 2023-December 2023
I was asked by my shift lead in Bacterin to help TCO department. This was due to low staff in TCO, several new colleagues who were still being trained to be in clean lab activities. I was already clean gown certified and had experience helping in this department. This also required me to go from second shift hours 1400-2030 to first shift hours 0600-1430. I was also asked to work every third weekend per the department activities.
Technician will start and finish a serial of vaccine (Prepare cell cultures, infect cells, harvest cells, blend serial and fill serial). Department takes embryos for further manufacturing.
Position Responsibilities
- Execution of aseptic techniques and clean room procedures or support area procedures in a GMP facility.
- Maintain appropriate departmental cGMP documentation.
- Execute all written procedures, to include Batch Records and SOPs.
- Follow and comply with all financial procedures.
- Follow and comply with all site safety procedures.
- Operation of departmental equipment to include set up and take down.
- Effectively work in a team environment and communicate with multiple departments.
- Follow good GMP practices.
- Clean room gowning required.
- Perform Aseptic processing skills while working in a clean room setting.
- Maintain accurate inventory.
- Follow Manufacturing Directions.
CEO: (Chick Embryo Origin) April 2018 to March 2019
- Perform and/or lead operations necessary in the Egg-Based and Poultry Antigen Production Area using aseptic technique.
- Perform chick embryo origin procedures utilizing associated equipment.
Position Responsibilities:
- Execution of aseptic techniques and clean room procedures or support area procedures in a GMP facility.
- Maintain appropriate departmental cGMP documentation.
- Execute all written procedures, to include Batch Records and SOPs.
- Follow and comply with all financial procedures.
- Follow and comply with all site safety procedures.
- Operation of departmental equipment to include set up and take down.
- Effectively work in a team environment and communicate with multiple departments.