Process Engineer III

At Freenome, we are seeking a highly skilled and motivated Process Engineer to join our dynamic team. As a Process Engineer, you will play a crucial role in the development and optimization of manufacturing/QC/Clinical Operations. The primary focus of the position is to critically evaluate laboratory/manufacturing/qc processes for variation and improvement for the multiomics colorectal cancer IVD product. The ideal candidate will drive the development and deployment of robust processes meeting metrics on safety, cost, quality, and supply. This engineer will impact the business by leveraging their knowledge of product and process development, scale up, compliance, continuous improvement, and troubleshooting in the commercialization and sustainability of novel in vitro diagnostic tests.

• Support the clinical lab by troubleshooting laboratory workflows involving NGS chemistry, protein immunoassay, laboratory equipment, and informatics infrastructure
• Collect, analyze, and interpret process data to identify trends, patterns, and areas for improvement
• Own NCR/CAPA actions to resolve process issues
• Define and own key process indicators in support of consistent quality of lab processes (capacity utilization, equipment downtime, CAPEX, SPC, CPK, etc.)
• Develop data dashboards and conduct data driven investigations to provide oversight of clinical lab operations
• Draft and own key quality documentation for processes (Process validation/IQ/OQ/PQ, work instructions, troubleshooting guides)
• Drive continuous improvement within the clinical lab to reduce test turnaround time, reduce COGS, and improve product quality
• Provide technical training and support to clinical/manufacturing personnel on new processes, equipment, and technologies
• Support the development of new products for Tech Transfer. This includes product pilot/design transfer planning and development of operational requirements
• Define validation plans/protocols for material assessment for robust supply chain management

• Bachelor's degree in Chemical Engineering, Biotechnology, Physics, or a related scientific field with at least 5 years of experience, or a Master's degree with 3 years of experience
• Training in process management/improvement philosophies (LEAN, Six Sigma, DMAIC, 8D)
• Solid background in process statistics
• Experience troubleshooting laboratory workflows involving NGS chemistry, protein immunoassay, laboratory equipment, and informatics infrastructure
• Ability to collect, analyze, and interpret process data to identify trends, patterns, and areas for improvement
• Knowledge of NCR/CAPA actions to resolve process issues
• Familiarity with key process indicators such as capacity utilization, equipment downtime, CAPEX, SPC, CPK, etc.
• Proficiency in developing data dashboards and conducting data-driven investigations for oversight of clinical lab operations
• Experience drafting and owning key quality documentation for processes (Process validation/IQ/OQ/PQ, work instructions, troubleshooting guides)
• Ability to drive continuous improvement within the clinical lab to reduce test turnaround time, reduce COGS, and improve product quality
• Strong technical training and support skills for clinical/manufacturing personnel on new processes, equipment, and technologies
• Knowledge of product pilot/design transfer planning and development of operational requirements for new products
• Familiarity with validation plans/protocols for material assessment for robust supply chain management

• Competitive base salary range of $102,000 - $155,000
• Eligibility for pre-IPO equity
• Cash bonuses
• Full range of medical, financial, and other benefits depending on the position offered
• Equal opportunity employer that values diversity
• No discrimination based on race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.