DESCRIPTION:

The main job purpose is to provide operational technical expertise to maintain pure culture within the
Fermentation plant by providing support on a day’s basis and providing critical operational
recommendations to ensure fermentations remain pure culture.

MINIMUM QUALIFICATION (EDUCATION, EXPERIENCE AND/OR TRAINING, REQUIRED CERTIFICATIONS):

• An excellent working knowledge of Fermentation operations and processes.
• An excellent working knowledge of maintaining pure culture operations.
• At least 2 years’ experience of working in a cGMP regulated manufacturing environment.

FUNCTIONS, DUTIES, TASKS

• Provide Pure Culture oversight for all fermentation operations.
• Evaluate findings from fermenter downtime operations and make go/no go
• recommendations from a pure culture perspective on proceeding to set the fermenter.
• Troubleshoot operational issues relating to pure culture.
• Second person verify critical pure culture operations
• Be a proactive coach across the operations group relating to pure culture and be a good influencer
• Execution of the routine Pure Culture Maintenance Programme eg assisting coil dye tests, header sterilisations, filter integrity testing
• Carry out non-routine sterility work
• Internal vessel inspections, including assisting coil dye tests
• Assist Pure Culture Group with foreign growth investigations carrying out the majority of the equipment testing and inspections.
• Determine best practice for pure culture operations
• Train Optechs in operations that impact pure culture control eg ; leak testing
• Ensure practice versus procedure for operations that impact pure culture.
• Be a part of the pure culture days group to implement improvements to the operations relating to pure culture
• Problem Solving: Use diagnostic and experience skills to assist operations group troubleshooting complex operational and pure culture related issues. Use of systems eg DeltaV and PI to aid diagnostics. Assist with investigations into foreign growth runs.
• Documentation: Completion of documentation to cGMP standards without error
• Training: Own ITP, share specialist skills and information gained through experience.
• Assist in development of Optechs learning plans and their implementation. Devise and
• write training material, train Optechs in pure culture operations