Process Engineer

Job Title : Process Engineer

Duration : 12 months on W2 Contract (Possible extension based on performance)

Location : Seattle, WA 98109

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

Schedule : Normal Business hours

Job Description : Top Skills Required-

• Proven ability to lead and drive projects within cross-functional teams, ensuring alignment and collaboration across multiple departments and organizations. Looking for a proactive and independent thinker.
• Extensive experience with change control processes, document approvals, and the management of Standard Operating Procedures (SOPs), Work Instructions (WIs), deviations, and Corrective and Preventive Actions (CAPAs) within a quality management system.
• Hands-on experience in the cell therapy field, particularly with CAR-T (Chimeric Antigen Receptor T-cell) products.
• Exceptional interpersonal and communication skills, with a demonstrated ability to build strong relationships and a positive reputation with various teams and stakeholders.

Top Skills :

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.

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Qualifications :