Engineer / Sr. Engineer, Operational Excellence

Physical Demands

• Production Associates: Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing color-coded components in a GMP environment.
• Must be able to meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for extended periods, as needed. Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed.

Work Conditions

• Must be able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs.
• Must be comfortable regularly participating in video-based meetings.
• May be required to work scheduled overtime, weekends, or holidays based on business needs.

Responsibilities

• Manufacturing Process Optimization: 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. 
• Metrics Development & Monitoring: 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. 
• Data Analysis & Reporting: 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. 
• Cross-Functional Collaboration: 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. 
• Project Management: Lead projects aimed at improving manufacturing processes and performance. Manage project timelines, budgets, and resources to ensure successful completion. 
• Compliance & Quality Assurance: 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. 
• Continuous Improvement Culture: Foster a culture of continuous improvement within the organization, encouraging employees to contribute ideas, solve problems, and implement solutions that drive operational excellence. 

Qualifications

• Bachelor's degree in a relevant field such as Biotechnology, Engineering, Manufacturing or Operations Management; advanced degree preferred. 
• 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). 
• Required: 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, certification a plus  
• 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.