Orca Bio · 1 month ago
Engineer / Sr. Engineer, Operational Excellence
Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies. They are looking for a results-driven Operational Excellence Engineer to focus on manufacturing optimization and the development of metrics to drive operational improvements, enhancing production efficiency and ensuring high-quality standards.
Health CareMedicalPharmaceutical
Responsibilities
Lead and implement continuous improvement initiatives aimed at optimizing manufacturing processes. Use Lean, Six Sigma, and other operational excellence tools to streamline production workflows, reduce waste, and increase overall efficiency
Define, implement, and monitor key performance indicators (KPIs) that track the efficiency, quality, and effectiveness of manufacturing operations. Develop dashboards and reporting tools to ensure real-time visibility into process performance
Collect and analyze data related to production metrics, production performance, cycle times, etc. Identify trends and areas of improvement and use data to drive decision-making for process enhancements
Work closely with operations, engineering, quality, and supply chain teams to understand challenges, identify bottlenecks, and optimize processes across departments. Facilitate communication between teams to ensure alignment on improvement initiatives
Lead projects aimed at improving manufacturing processes and performance. Manage project timelines, budgets, and resources to ensure successful completion
Ensure all manufacturing optimization activities comply with industry standards and regulations (e.g., GMP, ISO). Work closely with the quality team to ensure that improvements maintain or enhance product quality and safety
Foster a culture of continuous improvement within the organization, encouraging employees to contribute ideas, solve problems, and implement solutions that drive operational excellence
Qualification
Required
Bachelor's degree in a relevant field such as Biotechnology, Engineering, Manufacturing or Operations Management
3-5 years of experience (engineer level) or 6+ years of experience (senior engineer level) in manufacturing or operations optimization, preferably in a regulated environment (e.g., pharmaceuticals, medical devices, or biotechnology)
Lean certification (minimally green belt certified) – Including demonstrated experience applying Lean Six Sigma, and other operational excellence methodologies to manufacturing operations
Experience with data analysis, process optimization, and implementation of KPIs and performance metrics
Understanding of cell therapy manufacturing processes, regulatory requirements (GxP, GMP, FDA, EMA), or related industry standards
Proficient in data analysis tools (Excel, Minitab, etc.), statistical process control (SPC), and process modeling techniques
Strong understanding of Lean, Six Sigma, and other continuous improvement methodologies
Excellent analytical, problem-solving, and troubleshooting skills
Strong project management skills, with the ability to handle multiple projects simultaneously
Excellent written and verbal communication skills, with the ability to present data and findings to leadership and cross-functional teams
Preferred
advanced degree preferred
certification a plus
Benefits
Pre-IPO equity
Competitive medical, dental, and vision benefits
Flexible PTO
401(k) plan
Life and accidental death and disability coverage
Parental leave benefits
Free daily lunches and snacks at our on-site locations
Company
Orca Bio
Orca Bio is a clinical-stage cell therapy company dedicated to delivering curative medicine to patients.
H1B Sponsorship
Orca Bio has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (3)
2023 (1)
2021 (1)
2020 (1)
Funding
Current Stage
Late StageTotal Funding
$542MKey Investors
Lightspeed Venture PartnersSilicon Valley Bank
2026-01-09Series F· $250M
2026-01-09Debt Financing· $100M
2020-06-17Series D· $192M
Recent News
2026-01-12
Bizjournals.com Feed (2025-11-12 15:43:17)
2026-01-12
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