Engineering - Process Engineer Process Engineer

Job Description : Job Title : Process Engineer

Location : Seattle-Dexter, WA

Schedule : Normal Business hours

Hybrid : (50%+ days onsite required, days of week are flexible)

Top Skills :

• Life Cycle Management Experience
• Experience developing and implementing process improvement projects to improve robustness, scalability, and Cost of Goods (COGs) for cell therapy products.
• Familiarity with cell therapy processes and cGMPs
• Experience assimilating large data sets in support of batch history sections for regulatory submissions.
• Proficiency in data management / statistical analysis software, including Excel, JMP, and Spotfire is preferred.

Position Summary

Cell Therapy Technical Operations (CTTO) is responsible for global product lifecycle strategy and harmonization of Cell Therapy Manufacturing Processes across the manufacturing network throughout the product lifecycle. The Senior Engineer will be responsible for the implementation of cell therapy manufacturing technologies, and process changes related to the life-cycle management of a commercial CAR-T Therapy. This includes establishing the strategy for process changes, coordinating technical alignment, and lead implementation at a global level. This role collaborates across all CMC functional areas and drug product manufacturing sites to ensure project advancement, rapid and best-in-class execution, and communication of challenges / opportunities. The candidate will help drive the validation, qualification, and comparability strategies.

Duties / Responsibilities

Qualifications

The starting hourly compensation for this assignment is within the range of

Additional Job Requirements :

None

EEO :

"Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of - Minority / Gender / Disability / Religion / LGBTQI / Age / Veterans."