The Sr Engineer, Process Development (CLIA Lab) will work on the development and sustainment of our deployed clinical diagnostic products. The primary function of this position will be supporting system implementation, engineering and sustainment of our clinical diagnostic pipeline(s). The role will work closely with operations, product development, software development groups, and quality assurance. The ideal candidate will have experience interfacing with development teams and facilitating the import of lab protocols from product development into a clinical laboratory. Furthermore, the candidate should a have analytical skills and interest in interpreting data to drive process optimization and QC. Experience in molecular biology methods for nucleic acid applications, sequencing, and liquid handler automation would be beneficial.
All About You
- Work with and sometimes lead cross functional teams to support process changes or troubleshoot processes within the clinical laboratory.
- 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.
- 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.
- Analyzes process data to help drive sustainment and development efforts.
- Be a technical and integration representative for Operations on cross functional initiatives.
- Works closely with scientific, bioinformatics, engineering, software, quality, and commercial teams to develop, transfer, and sustain new products into the Clinical laboratory.
- Able to manage vendors on a technical level for development component delivery
- Mentors peers and supporting engineers on technical skills in one’s area of expertise
- Supports and troubleshoots existing processes and provides guidance on potential enhancements.
- 5+ years of experience
- Experienced in defining requirements for lab workflows and LIMS systems.
- Experience with NGS technology strongly preferred
- Familiar with automated liquid handlers such Biomek, Tecan and Hamilton.
- Statistical background for data analysis, process monitoring and QC.
- 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.
- BSc/MS with 5+ years of experience or PhD with 1+ years of experience