Orion Innovation is a premier, award-winning, global business and technology services firm. Orion delivers game-changing business transformation and product development rooted in digital strategy, experience design, and engineering, with a unique combination of agility, scale, and maturity. We work with a wide range of clients across many industries including financial services, professional services, telecommunications and media, consumer products, automotive, industrial automation, professional sports and entertainment, life sciences, ecommerce, and education.
Summary:
Manufacturing process experience in cell therapy or biologics (GxP)
Data Analysis / Process Monitoring (JMP, Python or similar statistical tools)
Computer System Validation within the biotechnology or pharmaceutical industry
Experience in implementing data solutions in commercial manufacturing environments
Clear communication across all levels
The primary focus of the Senior Specialist - MSAT Process Engineering is to provide support to the implementation of impactful projects that drive continued process verification and process monitoring at client GMP facility in Bothell, WA.
- Experience in process operations and support, including batch record review (cell therapy process experience preferred)
- 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
Key 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.
Qualifications & Experience
Specific Knowledge, Skills, Abilities:
- Demonstrated problem-solving skills with the ability to independently troubleshoot and resolve complex process challenges
- Demonstrated ability to effectively work in and lead cross functional teams, meet deadlines, and prioritize multiple projects
- 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
- Education/Experience/ Licenses/Certifications:
- BS and/or MS degree in chemical or bioprocess engineering, biotechnology, biosciences, or a related field
- Immunology education preferred
- 3+ years relevant experience in biologics or cell therapy manufacturing or development with BS, or 2+ years relevant experience with MS
- Preferred experience: cGMP, Lean/six sigma
Orion is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, creed, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, citizenship status, disability status, genetic information, protected veteran status, or any other characteristic protected by law.
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