Process Engineer – Fill Finish
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 standardization of single use assemblies and procedures. Work with supplier technical teams to maintain good relationship. Technical representative on site cross-functional team for design updates and introduction of new single use to site.
- Author of process flow diagrams for new product introductions / technology transfers. Responsible for aligning PFD between products and standardizing 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.
- Other duties as assigned.
Requirements
- Third level degree in Chemical Engineering, Bioprocess Engineering 3-5 years’ experience in biopharmaceutical industry.
Essential
- Biologics experience with at scale manufacturing in fill finish facility in a technical role.
- Experience with new product introductions / technology transfers to fill finish manufacturing facility.
- Experience in single use technology
- Experience in isolator technology
- Experience in SAP / Trackwise
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