MSAT Process Engineer (Onsite- Bothell, WA)

MSAT Process Engineer (Onsite- Bothell, WA) (Bothell, WA, 98021) | 04/27/26 Easy Apply Share Job Job Description MSAT Process Engineer (Onsite - Bothell, WA) We are seeking an MSAT Process Engineer for our global pharmaceutical client. The primary focus of this role is to provide support to the implementation of impactful projects that drive continued process verification and process monitoring at client's GMP facility in Bothell, WA. This is a 40-hour per-week, 9-month contract (extensions possible), onsite at the client's office in Bothell, WA. This is a W2 role as a Stage 4 Solutions employee. Health benefits and a 401K are offered.

RESPONSIBILITIES

Functions as a technology, product, and process subject matter expert; may serve as system SME on one or more manufacturing unit operations Drive and support the implementation and deployment of an automated CPV and process monitoring tool aligned with Quality System and business requirements Execute data driven initiatives that enhance quality, improve operational efficiency, support local and global reporting, and strengthen data handling processes. Lead or assist in designing, testing, and deploying manufacturing analytics solutions Translate business and process requirements into functional and design specifications to support system configuration and implementation Perform process monitoring activities, including collecting, organizing and evaluating data to support CPV Analyze trends of clinical and commercial production data to drive actions for manufacturing process improvement Apply continuous improvement/lean tools to identify opportunities for process improvements and operational efficiencies, and drive cross-functional projects to implement Communicate insights, risks, and recommendations to cross-functional stakeholders in clear, concise, actionable formats. Provides support for data extraction and verification to enable the implementation of an automated tool for CPV and process monitoring Cross-functional collaboration required between site MSAT, IT, vendors and global team, and partnership with Project Management to integrate all technical deliverables within a single comprehensive project plan to ensure successful implementation of capital projects Gather functional requirements and architect end-to-end solutions for scaling analytical capabilities Supports routine process monitoring for drug products currently manufactured at the Bothell facility, to help identify process improvement and opportunities to gain efficiency Makes data driven decisions and recommendations Leads MSAT driven cross-functional and cross-site projects Routinely collaborates with global teams, other CTDO sites and vendors

REQUIREMENTS

3+ years relevant experience in biologics or cell therapy manufacturing or development. Manufacturing process experience in cell therapy or biologics (GxP) is required Proficient in Data Analysis / Process Monitoring (JMP, Python or similar statistical tools Must have Computer System Validation within the biotechnology or pharmaceutical industry Experience in implementing data solutions in commercial manufacturing environments Experience in process operations and support, including batch record review (cell therapy process experience preferred) Able to apply engineering principles and statistical analysis to resolve processing issues and evaluate process improvement opportunities Demonstrated scientific and technical acumen including technical writing skills Preferred experience in cGMP, Lean/six sigma. BS and/or MS degree in chemical or bioprocess engineering, biotechnology, biosciences, or a related field. Immunology education is preferred