Staff Systems Engineer - Clinical LabIllumina, Inc.
The Staff Systems Engineer (Clinical Lab) will work on the development and sustainment of our deployed clinical diagnostic products. The primary function of this position will be to lead automation of molecular diagnostic assay workflows using liquid handling systems for implementation for patient care. The role will work closely with operations, product development, software development groups, quality and commercial teams. The ideal candidate will have experience interfacing with development teams, leading teams from concept to launch, facilitating transfer of lab protocols from product development into a clinical laboratory, and driving data based decisions. The automation team is responsible for transitioning manual workflows and processes on to semi/fully automated robotics platforms as appropriate and provide ongoing support and continuous improvement of these systems.
- Leads teams of engineers supporting projects for Clinical Laboratory operations.
- Drive optimization of existing automated processes to improve efficiency, throughput, robustness and quality
- Oversee transition of manual workflows onto automated liquid handlers
- Author, execute and document test plans and Standard Operating Procedures (SOPs) for automated workflows
- Provide support for existing equipment and coordinate vendor support as required
- Monitor and evaluate new and emerging technologies in laboratory automation systems Perform other duties as assigned
- Able to create requirements, plan activities and contribute to budget of allocated project scope, and prioritization of activities/assignments to supporting team members.
- Able to identify risk and provide recommendations for risk mitigation in area of responsibility and at project level.
- Design and execution of experiments to support process changes.
- Queries and analyzes process data to help drive sustainment and development efforts.
- Able to own a large subsystem or workflow, without needing oversight.
- Development/sustainment of methods on automated liquid handlers
- Supports Clinical laboratory and product development process engineering needs.
- Be a technical and integration representative for Operations on cross functional initiatives.
- Collaborate with scientific, bioinformatics, engineering, software and commercial teams to develop, transfer, and sustain new products into the Clinical laboratory.
- Supports and troubleshoots existing processes and provides guidance on potential enhancements.
- Configure, program and troubleshoot laboratory automated platforms
All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.
- Minimum 3-5 years hands on experience in automation and liquid handling
- Proficiency in both writing and optimizing scripts on automated liquid handling platforms (e.g., Hamilton, Tecan, Beckman, etc.,)
- Experience in driving continuous improvement projects
- Six Sigma strongly preferred
- Experience with writing and executing test protocols
- Experience with NGS methods is strongly preferred
- Excellent data and business analytics
- SQL, R, Python, JMP, Tableau experience preferred
- Statistical background for data analysis, process monitoring and QC.
- Effective organizational and time management skills. Highly energetic and self-motivated. Able to work independently and as part of a team.
- Experience working in a clinically regulated environment is highly desirable
- Experienced in defining requirements for lab workflows and LIMS systems.
- Background with validation and verification processes in a regulated laboratory.
- Ability to think innovatively toward solving problems effectively and efficiently.
- Adept inter-personal skills to contribute to cross functional project teams and work with stakeholders.
- Excellent problem solving and analytical skills
- Excellent written and communication skills
- BSc/MS: 8+ years of experience
- Masters 5+ years of experience
- PhD: 3+ years of experience
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