Job Description:
As a Process Engineer for Fill Finish Manufacturing, you will play a critical role in the design and commissioning of aseptic fill finish manufacturing equipment. You will leverage your detailed understanding of the process to ensure seamless integration and qualification of new systems.
Key Responsibilities:
* Process Engineer for Fill Finish Manufacturing site
* Leverage detailed understanding of aseptic fill finish manufacturing for design input into equipment commissioning and qualification.
* Responsible for single use design, onboarding, and qualification. Act as site representative on cross-site teams for standardisation of single use assemblies and procedures. Work with supplier technical teams to maintain good relationship.
* Author of process flow diagrams for new product introductions / technology transfers. Responsible for aligning PFD between products and standardising for NPI. Aligns with NPI Lead for product transfer on requirements for new products or process improvements.
* 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.
* Author scientific reports and technical documentation and presentations to document and communicate project status to internal and external stakeholders.
* Understand and ensure compliance with safety, regulatory and compliance expectations.
Requirements:
1. Third level degree in Chemical Engineering, Bioprocess Engineering
2. Experience in biopharmaceutical industry.
3. Biologics experience with at scale manufacturing in fill finish facility in a technical role.
4. Experience with new product introductions / technology transfers to fill finish manufacturing facility.
5. Experience in single use technology
6. Experience in isolator technology
7. Experience in SAP / Trackwise