Fermentation Engineer

Job Summary 

This position is responsible for providing technical support to the Engineering teams for managing vendors, commissioning testing, and design review. The individual must have the ability to write reports clearly, concisely and accurately.  A basic understanding of current Good Manufacturing Practices (cGMP) is also required to perform these duties. Knowledge of controls is a plus. 

Responsibilities 

• Performs specification, procurement, commissioning, and operation of API processing equipment (reactors, mix tanks, centrifuges, various types of filters, dryers, and drum filling equipment). 

• Performs commissioning studies (utility, equipment, cleaning, process computer, and new products) which can also include writing Risk Assessments, protocol preparation, scheduling, protocol execution, and final report preparation.

• Programs and operates department analytical instruments (such as temperature/humidity dataloggers) to perform controlled temperature/humidity chamber qualifications (examples lyophilizers, warehouses, sterilizers, incubators, etc.). 

• Represents Technical Services in teams assembled to specify, install, troubleshoot and maintain systems, equipment and processes. 

• Responsible for managing multiple deviation investigations simultaneously. 

• Provides follow up and scheduling to qualification process is not impacted by outstanding deviations. 

• Works with process experts and production personnel to fully understand and solve problems, 

• Provides technical expertise and recommends improvements. 

• Utilizes Word, Excel, Documentum and other electronic systems to complete tasks. 

• Maintains compliance with company policies, training requirements, cGMPs and safety standards. 

• Perform any other tasks/duties as assigned by Management. 

Requirements 

• Minimum 4-year degree in a Science or Engineering field of study 

• 1-3 years' of applicable cGMP manufacturing experience, writing standard operating procedures and protocols and/or reports. Familiar with regulatory (FDA) requirements.

• Ability to communicate clearly and concisely when conveying information, summarizing facts, asking questions, etc.