Process Engineer

Job Title: Process Engineer

Location: Seattle-Dexter, WA

Hours/Schedule: Normal Business hours

Compensation: $55.06 – $69.93/hr

Type: Contract

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

Requirements

• 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

Benefits

System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.

Ref: #568-Clinical

System One, and its subsidiaries including Joulé, ALTA IT Services, TeamPeople, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

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