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:

• 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:

• Lead the commercial lifecycle plan for a cellular product, maintain oversight of process capability through data trending and statistical analysis of critical variables, ensure processes are robust, in a continued state of validation, and continuously improving.
• Develop and implement process improvement projects to improve robustness, scalability, and Cost of Goods (COGs) for cell therapy products.
• Develop product technical strategies including manufacturing requirements, process improvement plans, and ensure successful and timely execution working across functional groups.
• Provide technical content for significant documents such as validation activities, author content for regulatory submissions.
• Ensure technical and manufacturing requirements are addressed throughout lifecycle of new solutions.
• Provide necessary technical analysis to support impact assessments and investigations.
• Function as a subject matter expert for autologous T-cell therapies and manufacturing technologies.
• Provide technical input and requirements for design of future clinical and commercial manufacturing facilities.
• Present complex technical topics internally and externally.
• Share operational and process leanings with the rest of the manufacturing network

Qualifications:

• Bachelor's or Graduate degree in Chemical Engineering, Biomedical Engineering or Life Sciences with more than 5 years of experience in Biotech industry. Familiarity with cell therapy processes and cGMPs is preferred.
• Ability to effectively work in cross functional teams, meet deadlines as an individual contributor, and prioritize responsibilities.
• Experience working in a self-driven, performance/results oriented, fast paced matrix environment.
• 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.
• Excellent problem-solving skills, including issue resolution, root cause investigations and CAPAs.
• Ability to assess risk and develop contingency plans for process risks
• Able to manage time and elevate relevant issues to project lead and line management.
• Detail oriented with excellent verbal and written communication skills.
• Strong interpersonal and leadership skills to work with teams in different functions and organizations.