Senior Process Engineer: Clinical NGS Automation & Equity

San Diego Stealth Startup; San Diego (CA); Presencial; USD 131.000 - 140.000; Jornada completa

Descripción de la vacante

San Diego Stealth Startup is seeking a Senior Process Engineer to drive automated development, productionalization, and validation of clinical NGS assays. This hands-on IC role translates bench chemistry into robust, auditable workflows for clinical deployment.

The role collaborates with assay development, automation, quality, and operations to design and qualify automated methods for library prep, extraction, and QC, applying DOE/SPC and aiming for scalable, compliant processes in an

Formación

• BS/MS in Chemical Engineering, Bioengineering, Biochemistry, Biotechnology, or a related field.
• 6+ years of process engineering or process development within clinical diagnostics, NGS, biotech, or other regulated laboratory environments.
• Hands-on experience developing and optimizing automated laboratory workflows, including direct protocol development on liquid handling platforms.
• Demonstrated experience supporting clinical or near-clinical NGS assays, including library preparation, nucleic acid extraction, methylation conversion, or sample QC workflows.
• Prior experience supporting LDT and/or FDA-regulated IVD assay development. Working knowledge of design controls and regulated development frameworks (ISO 13485, IVD or LDT context), with experience operating in a quality-driven environment.
• Practical fluency in data-driven process development methods — DOE, statistical process control, Gage R&R, root cause analysis.
• Ability to operate independently across multiple workstreams in an early-stage environment where requirements evolve.
• Comfort operating in a stealth-stage, resource-constrained environment where processes are being built from the ground up.

Responsabilidades

• Develop, optimize, and qualify automated workflows for NGS library preparation.
• Partner with assay development scientists to transfer bench-developed chemistry onto automation platforms, identifying and resolving robustness, scaling, and operability issues.
• Apply DOE, SPC, and other statistical tools to characterize process performance, define operating windows, and establish in-process and release specifications.
• Contribute to reagent and consumable manufacturing and qualification activities, including QC method development and lot release strategy.
• Execute equipment qualification activities (IQ/OQ/PQ) for automation and ancillary instrumentation in partnership with engineering and lab operations.
• Support development and maintenance of process documentation, including process maps, equipment lists, and bills of materials, in alignment with design control expectations.
• Participate in tech transfer of NGS assays to the clinical laboratory, supporting validation activities and resolving process issues that surface during scale-up and deployment.
• Partner cross-functionally with chemistry, automation, software, quality, and lab operations to drive sustainable process improvements.

Conocimientos

DOE

SPC

Gage R&R

Root cause analysis

Data-driven process development

Independent cross-stream work

Stealth-stage environment

Educación

BS/MS in Chemical Engineering, Bioengineering, Biochemistry, Biotechnology, or related field

Herramientas

Liquid handling platforms

Descripción del empleo

San Diego Stealth Startup is seeking a Senior Process Engineer to drive automated development, productionalization, and validation of clinical NGS assays. This hands-on IC role translates bench chemistry into robust, auditable workflows for clinical deployment.

The role collaborates with assay development, automation, quality, and operations to design and qualify automated methods for library prep, extraction, and QC, applying DOE/SPC and aiming for scalable, compliant processes in an