Engineer, Operational Excellence

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� Description

• • Drive the future of cell therapy manufacturing by embedding world-class operational excellence at Orca Bio’s 100,000-sq-ft GMP facility in Sacramento. You will own end-to-end optimization of manufacturing workflows for life-saving, high-precision cell therapies, translating cutting-edge science into repeatable, scalable, and compliant production processes.
• • Lead Lean/Six Sigma initiatives that eliminate waste, reduce cycle time, and increase throughput while maintaining the highest quality standards. Your work will directly impact patient access—every minute saved and every defect prevented brings us closer to delivering safer, more effective transplants to the >1 million Americans battling blood cancer.
• • Design, deploy, and maintain a real-time KPI dashboard ecosystem that gives operators, engineers, and executives instant visibility into OEE, yield, right-first-time, and cost-per-dose metrics. You will turn raw data into actionable insights that guide daily decisions and long-term strategy.
• • Partner with cross-functional teams—Manufacturing, Quality, Supply Chain, Regulatory, and Facilities—to map current-state value streams, identify bottlenecks, and implement future-state solutions. You will facilitate kaizen events, coach green-belt candidates, and institutionalize a culture of continuous improvement.
• • Own the full project lifecycle for high-impact CI projects: scope definition, financial justification, resource planning, timeline management, risk assessment, validation, and post-implementation review. Projects may range from single-piece flow cell-washing lines to automated environmental monitoring systems.
• • Ensure all process changes comply with FDA, EMA, and GMP requirements. You will author or review change controls, validation protocols, and SOPs, working hand-in-hand with Quality Assurance to guarantee patient safety and data integrity.
• • Analyze large, complex data sets using Excel, Minitab, or similar tools to uncover root causes of variation. Apply statistical process control (SPC), design of experiments (DOE), and predictive modeling to achieve robust, capable processes.
• • Champion a “gemba-first” mindset—spend at least 50 % of your time on the production floor observing, listening, and coaching. Capture operator feedback, rapidly prototype solutions, and celebrate wins to sustain momentum.
• • Mentor junior engineers and technicians on Lean tools, problem-solving methodologies, and data-driven decision-making. Build internal capability so that continuous improvement becomes everyone’s job, not just yours.
• • Support tech-transfer activities as new products move from clinical to commercial scale. Collaborate with Process Development to ensure manufacturability, draft batch records, and lead PPQ campaigns.
• • Prepare and deliver concise, compelling presentations to senior leadership. Translate technical findings into business impact—cost savings, capacity gains, risk reduction—and secure ongoing investment in operational excellence.
• • Contribute to a start-up culture where agility, curiosity, and courage are valued. Embrace calculated risks, ask “why not,” and challenge the status quo in pursuit of breakthrough therapies.

� Requirements

• • Bachelor’s degree in Biotechnology, Engineering, Manufacturing, Operations, or related field; advanced degree preferred
• • 3–5 years of manufacturing or operations optimization experience in a regulated pharma, biotech, or medical-device environment
• • Lean Six Sigma Green Belt certification (minimum); Black Belt or Master Black Belt strongly preferred
• • Demonstrated success applying Lean, Six Sigma, SPC, and KPI development to drive measurable improvements in yield, OEE, or cost per unit
• • Proficiency with data analysis tools such as Excel, Minitab, JMP, or equivalent; experience building dashboards in Power BI or Tableau a plus
• • Working knowledge of GMP, FDA, EMA regulations, and validation principles for cell therapy or biologics manufacturing

️ Benefits

• • Competitive base salary of $85,000–$105,000 plus pre-IPO equity participation
• • Comprehensive medical, dental, and vision coverage starting day one
• • Flexible PTO policy, 401(k) with company match, life insurance, and parental leave
• • Daily catered lunches and fully stocked micro-kitchens at both Sacramento sites
• • Opportunity to directly impact patients’ lives while growing within a mission-driven, high-growth biotech