Fermentation Engineer

North Chicago, IL - USA

Monthly Salary: Not Disclosed

Posted on: 7 days ago

Vacancies: 1 Vacancy

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 alsoinclude 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
1-3years of applicable cGMP manufacturingexperience 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.

Required Experience:

Junior IC

Job SummaryThis 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 P...

Job Summary

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 alsoinclude 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
1-3years of applicable cGMP manufacturingexperience 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.

Required Experience:

Junior IC