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.

• 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 data loggers) 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 ensure the 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.
• Performs any other tasks/duties as assigned by management.

• 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 and asking questions.

Entry level

Full‑time

Engineering and Information Technology

Internet Publishing