Just Evotec Biologics is seeking a Principal Process Engineer to drive impactful projects, collaborate with bright minds, and explore uncharted territories. As a Principal Process Engineer, you'll have the freedom to ask hard questions, think outside the box, and find creative solutions that push the company forward.
Requirements
- Project Lead for technology transfer of a Late-Stage molecule/commercial manufacturing and/or PPQ campaign support
- Lead site to site Tech Transfer activities
- Lead technology transfer activities ensuring gap analysis/risks assessments are performed and mitigation plans are in place and ensuring design spaces (PAR & NOR ranges) are built for critical process parameters for validation and support of late stage/commercial manufacturing operations
- Support development, review and approval of technical documentation including global protocols for performance qualifications, batch records, and reports related to engineering, GMP and PPQ runs
- Lead the development and implementation templates for Process Validations and Continued Process Verification strategies
- Lead the analysis of process data including annual periodic reviews across the network of Manufacturing sites
- Develop Process transfer document and/or Process Control strategy for phase III and commercial programs for receiving sites across the MFG network
Benefits
- Discretionary annual bonus
- Comprehensive benefits to include Medical, Dental and Vision
- Short-term and long-term disability
- Company paid basic life insurance
- 401k company match
- Generous paid time off and paid holiday
- Wellness and transportation benefits