As part of the Process Development team within the Engineering Department of Operations, you as the Senior Process Engineer / Scientist, will play a pivotal role in the design and development of new, and the improvement of existing, diagnostic genomic tests run in our state-of-the-art Clinical Laboratory utilizing tissue- and fluid-based patient samples. Starting with business and user requirements, you will participate in all aspects of process development including conceptualization, requirements definition, risk analysis, manual process development to automation transfer, optimization, troubleshooting, and verification and validation. You will work with diverse partners (e.g. research, quality, biostatistics, laboratory operations) in cross-functional teams to ensure, through careful planning and execution, that developed processes are highly robust, scalable, and meet stringent performance and operational requirements.
Lead and contribute to the design, development, optimization, verification and validation, and transfer of automated processes, systems, and workflows for genome-based assays (NGS, quantitative PCR, etc.).
- Lead and contribute to the design and execution of experiments with well-organized and documented analysis to drive decision making.
- Mentor engineers and scientists on best practices in process and product development.
- Write and review experimental protocols, study reports, IOPQ documents, and SOPs, incorporating input from other team members efficiently and effectively.
- Establish realistic timelines for execution and communicate with partners.
- Drive the establishment of process requirements from cross-functional partners.
- Work in cross-functional teams to provide troubleshooting expertise on developed processes.
- Evaluate off-the-shelf instruments, software, and reagents for incorporation into processes.
- Analyze workflows, identify bottlenecks, and make suggestions for process improvements.
- Represent Process Engineering on cross-functional teams.
- Support the best principles of Clinical Laboratory Improvement Amendments (CLIA), Good Laboratory and Clinical Practices (GLP/GCP) and ISO 13485 design control in product development as appropriate (e.g. requirements documents and design history files).
- Other responsibilities as assigned.
- A B.S. degree in engineering (preferably biomedical, chemical, or systems engineering) or science (preferably in molecular biology, genetics, biochemistry, or a closely-related discipline) and a minimum of 10 years of related experience. An M.S. with 8+ years of related work experience or a Ph.D. with 5+ years of related work experience will also be considered.
- Experience in streamlining workflows and developing automated laboratory processes and systems, including collecting and documenting requirements, developing concepts, design, verification and validation, implementation, and transfer/training.
- Experience with operating liquid handling robotics platforms.
- Demonstrated ability to contribute to and lead cross-functional process development, improvement, and troubleshooting teams.
- Strong written and oral communication skills with a commitment to maintain open and transparent communication with internal employees, managers, and customers as needed.
- Experience collaborating with internal and external colleagues and customers from diverse scientific, engineering, operational, and regulatory disciplines.
- A track record of successfully completing complex assignments and meeting goals within aggressive timelines.
- Experience monitoring data quality and troubleshooting technical problems.
- Excellent organizational and planning skills.
- Experience with standard molecular biology techniques such as nucleic acid isolation, purification and quantitation, qPCR or next generation sequencing.
- Proficiency in using basic word processing and spreadsheet applications.
- Ability to integrate and apply feedback in a professional manner.
- Ability to prioritize and drive to results with a strong commitment to quality.
- Experience with ISO 13485, ISO 9001, and 21 CFR 820 quality systems
- Experience with using Laboratory Information Management Systems (LIMS)
- Experience programming a variety of liquid handling robotics platforms
- Experience programming VBScripts
- Knowledge of TECAN EVOWare and/or Hamilton Venus scripting languages
- Familiarity with change control, Six Sigma, Lean Manufacturing, Kaizen, DOE principles
- Experience with statistics and statistical software tools (e.g. JMP, SAS, etc.)
- Ability to perform laboratory activities including nucleic acid extraction, reverse transcription, quantitative PCR and next generation sequencing utilizing various technologies
Travel, Physical/Mental Demands and Work Environment
- Travel Requirements: 10% Travel
- Standing or sitting for long periods of time may be necessary
- Some lifting (greater than 25 pounds) may be necessary
- May be exposed to hazardous materials such as human tissues and fluids, instruments with moving parts, lasers, heating and freezing elements, and high speed centrifugation