Process Engineer - Fill Finish
Responsibilities:
1. As the Process Engineer for our Fill Finish Manufacturing site, you will leverage your in-depth understanding of aseptic fill finish manufacturing to inform design input during equipment commissioning and qualification.
2. You will be responsible for single-use design, onboarding, and qualification, as well as serving as the site representative on cross-site teams for standardizing single-use assemblies and procedures.
3. Additionally, you will work with supplier technical teams to maintain a strong relationship and serve as the technical representative on the site's cross-functional team for design updates and introductions of new single-use technologies.
4. You will author process flow diagrams for new product introductions and technology transfers, ensuring alignment between products and standardizing for New Product Introductions (NPI).
5. The Technical SME for investigations, you will be responsible for process improvements and monitoring of process efficiency.
6. You will author gap assessments, facility fit studies, process safety and risk assessments for NPI.
7. Further, you will author scientific reports and technical documentation, as well as present project status to internal and external stakeholders.
8. You will ensure compliance with safety, regulatory and compliance expectations.
9. This role involves other duties as assigned.
Requirements:
* A Third-level degree in Chemical Engineering or Bioprocess Engineering is required, along with 3-5 years' experience in the biopharmaceutical industry.
Essential Experience:
* Biologics experience with at-scale manufacturing in a fill finish facility in a technical role.
* Experience with new product introductions/technology transfers to fill finish manufacturing facilities.
* Experience in single-use technology.
* Experience in isolator technology.
* Experience in SAP/Trackwise.