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Job Description

About the role:

The role is responsible for executing all processes in production while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations which could apply. In addition to making routine revisions to documents, he/she may rewr it e c omplex procedures or initiate new procedures as applicable. The incumbent has enough applied technical knowledge to perform complex trouble shooting tasks and may even assist during the transfer of new technologies into manufacturing. He/She has sufficient technical and administrative competence to organize and lead production activities, including demonstrating leadership in state-of-the-art cGMP compliance, and environmental health and safety skills.

How you will contribute:

• Prepare media and buffer solutions.

• Operate Clean-in-Place (CIP) and Steam-in-Place systems.

• Assemble and operate filtration systems.

• Operate general production equipment (such as pH and conductivity meters, autoclave, portable mixers, etc.)

• Monitor and record critical process parameters.

• Complete all relevant paperwork following GDP/GMP guidelines.

• Perform routine maintenance and cleaning of production equipment to maintain in GMP fashion.

• Perform sampling using aseptic techniques.

• Participate on Continuous Improvement Teams.

• Train and mentor other team members.

• Write, revise and review pertinent documentation as appropriate.

• Troubleshoot process problems and respond to process alarms.

• Assist with process/equipment validation and data analysis.

• Work with other groups such as maintenance/metrology to ensure preventative maintenance is done.

• Initiate and/or coordinate other process improvement projects.

• May perform other duties as assigned.

• Knowledge of cGMP manufacturing.

• Knowledge of basic laboratory and pharmaceutical production equipment