SomaLogic, Inc. Senior Engineer, Systems Development and Integration in Boulder, Colorado
SomaLogic is a privately-owned bio-information science company that developed a revolutionary proteomics technology (SomaScan® assay) capable of measuring thousands of different human proteins in a single small sample. We are now moving towards commercializing the health-related information derived from that technology to help people worldwide proactively manage their health for life. As a part of our commercialization effort, we are seeking additional expertise to join our dedicated team of scientists, bioinformaticians, statisticians, and software developers to help us realize that vision.
We are seeking a talented and hands-on Engineer II/Senior/Associate Director Process and Integration Engineer to augment the existing capabilities and skills in the Systems Development and Integration Group. The ideal candidate will combine superb technical, research and analytical capabilities with a demonstrated ability to work quickly and effectively in a fast-paced environment. The Systems Development and Integration group is responsible for the integration of biochemical processes and the development of robotic/automation systems. These activities include the transfer of procedures from research into manufacturing, performing systems validation and verifications, addressing process/product scale up requirements and work on product and process improvements. In addition, the group is working on the biochemical optimization of SomaLogic’s proprietary proteomic assay including development of control systems and strategies, and development of cost reduction measures. The work contributes to regulatory filings.
The level of the role will be commensurate with experience of the selected candidate.
Key Job Responsibilities:
Work with outside vendors and contractors for design, improvements and implementation of equipment
Develop liquid handling protocols on Tecan Evo and Tecan Fluent equipment.
Participate in the development of custom equipment. This includes defining design input requirement, establishing operating parameters, and specifying calibration procedures.
Validation of custom equipment using design control processes.
Troubleshoot equipment failures using CAPA and FMEA processes. This includes defining, implementing, and testing design modifications to ensure the reliability and functionality of equipment.
Participate in design reviews and make recommendations for measuring and improving product quality and reliability
Regular communication of technical results in cross-functional team meetings associated with specific projects.
Manage timely execution of design control activities, e.g. process/product, transfer and qualification for new product introductions.
Generate documentation within SomaLogic’s Quality Management System. This includes preparing standard operating procedures, IQ/OQ/PQ Plans, equipment operating and maintenance instructions, changeover procedures, batch records, validation plans, validation reports, and technical reports
Work collaboratively with SomaLogic’s various line functions, including Assay Services, Manufacturing, Assay R&D, Technology Research, Bioinformatics, IT, Regulatory and Operations to meet project goals
Degree in biomedical or mechanical engineering, materials science, applied physics, or other relevant engineering fields and
o PhD with 4+ years relevant experience preferred, or
o Master’s degree with 12+ years relevant experience, or
o Bachelor’s degree with 14+ years relevant experience preferred
Skills and experience
Multiple years of hands on experience in a role designing, assembling, troubleshooting, and validating complex scientific equipment and production workflows, preferably in biotech
Highly skilled in at least one of the following with working knowledge of the others:
· Mechanical engineering
· Biological Sciences
· Medical devices or laboratory automation
· Process engineering
· Electrical engineering
· Chemical engineering
Proficiency programming with Python, R Studio, Java, Igor Pro, Matlab, or other programming languages
Ability to work in a fast-paced environment with strict deadlines
Effectively manage schedule and priorities with minimal daily supervision to meet mid to long-range program objectives. Accomplish program objectives by taking ownership of assigned tasks.
Superb time management and organizational skills
Excellent verbal and written communication skills
Demonstrated computer skills with word processing, spreadsheets, graphics, and statistical tools
Experience in a regulated testing environment (ISO/FDA) desired, familiarity with GMP
· Proficiency with Tecan, Beckman, Hamilton or other liquid handling platforms
· Experience working with DNA microarrays
· Working knowledge of proteomics
We are a fun and passionate team from diverse backgrounds
Work is split between a typical office environment, a typical biochemistry laboratory (regulated and non-regulated) with Personal Protective Equipment use required.
The work environment may include, but is not limited to, the following hazards: chemical, electronic, mechanical, biohazard waste and infectious material