
Manufacturing Efficiency Specialist
2 weeks ago
Key Responsibilities:
- Leverage your in-depth knowledge of aseptic fill finish manufacturing to drive input into equipment commissioning and qualification.
- Responsible for the development, onboarding, and qualification of single-use assemblies.
- Act as a technical representative on cross-site teams for standardization of single-use procedures.
- Collaborate with supplier technical teams to maintain effective relationships.
- Technical representative on site cross-functional team for design updates and introduction of new single use to site.
- Author 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 stakeholders.
Requirements:
- 3+ years biologics experience in aseptic processes, experience in single-use technology and isolator technology.
- 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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