Principal Process Engineer - Site Based, Redmond, WA

Just Evotec Biologics is seeking a Principal Process Engineer to join their team. The role involves project leadership for late-stage molecule process transfer, tech transfer, and commercial biologics manufacturing. The selected candidate will support the implementation of network alignment strategy and creation of global templates/documentation for Tech transfer/New Product introduction across JUST Evotec Manufacturing network. The team member will also provide onsite support for new facility or client startup engineering runs and performance qualification runs, assist in generation of relevant regulatory submissions, and provide support for regulatory and site inspections.

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