Process Engineer – Fill Finish
Responsibilities:
* Leads aseptic fill finish manufacturing site as a Process Engineer.
* Utilizes in-depth knowledge of aseptic fill finish manufacturing to provide design input for equipment commissioning and qualification.
* Responsible for single-use design, onboarding, and qualification, serving as the site representative on cross-site teams for standardization of single-use assemblies and procedures.
* Collaborates with supplier technical teams to maintain good relationships and represents the site on cross-functional teams for design updates and introduction of new single-use technologies.
* AUTHORS process flow diagrams for new product introductions/technology transfers, ensuring alignment between products and standardizing for NPI.
* Serves as a technical SME for investigations, responsible for process improvements and monitoring of process efficiency.
* AUTHOR gap assessments, facility fit studies, process safety, and risk assessments for NPI.
* Authors scientific reports and technical documentation, presenting project status to internal and external stakeholders.
* Ensures understanding and compliance with safety, regulatory, and compliance expectations.
* Performs other duties as assigned.
Requirements:
Educational Background:
* Third-level degree in Chemical Engineering or Bioprocess Engineering.
Essential Experience:
* Biologics experience with at-scale manufacturing in fill-finish facilities in a technical role.
* Experience with new product introductions/technology transfers to fill-finish manufacturing facilities.
* Proficiency in single-use technology.
* Experience with isolator technology.
* Familiarity with SAP and Trackwise.