Sr Process Development Engineer, Instrumentation

San Diego, CA
Operations – Process Development
Full Time
Element Biosciences is a multi-disciplinary startup focused on innovating genetic analysis tools for the research and clinical markets. The Company's technology will broaden the end user experience through improved data quality and simplified workflows to benefit discoveries and diagnosis in healthcare.

We are looking for a driven, passionate professional to co-develop our processes with our products.  We look for flexible candidates eager to build an amazing company and launch an amazing product!  The Process Development team is integrated with our technology and product development teams, with a focus on pulling the technology out of the lab and enabling it in Operations.

Senior Process Development Engineer will play a critical role in technology development, new product development and sustaining engineering in a fast-paced environment. They will be instrumental in testing, process development and pilot build/integration activities.  Front loading the R&D activities with Process Development in mind will be a key attribute and culture that this role will participate in.

Responsibilities:

    • Build documentation for user and system requirements, participate in product architecture and design, participate in risk analysis, and support integration and testing activities.
    • Design and execute experiments (i.e. DOEs) in collaboration with development engineering to define production design and process parameters.
    • Work with development scientists and engineers to establish protocols and translate to standard operating procedures.
    • Analyze data to recommend statistically supported solutions for component and subsystem designs.
    • Participate in pilot and early stage production activities including manufacturing, testing, and troubleshooting.
    • Develop work instructions and procedures for production personnel as well as conduct training, including effectiveness.
    • Support system level integration and test efforts for complex fluidic, mechanical and optical systems.
    • Write and execute equipment IQ/OQ/PQ and process OQ/PQ validations.

Requirements:

    • Successful candidates will have work experience in the biotechnology or device manufacturing fields.
    • Minimum Bachelors degree with 5 years work experience.
    • Experience in both Development and Operations settings is desirable.
    • Statistical data analysis and visualization (such as miniTab, JMP or R) is desirable.
    • Experience with oscilloscopes, signal generators, optical power meters, logic analyzers, and spectrum analyzers.
    • Experience in Lean principles, Design For Manufacturability and continuous improvement activities.
    • Experience in SolidWorks modeling, drawing and assemblies preferred.
    • Experience in pilot/full-production environments, including tech transfer activities, sustaining support, and continuous improvement is required.
    • Experience with cGMP and cGDP is required.
    • Must have excellent communication skills, the ability to multitask, work with a team and independently, and the ability to troubleshoot technical issues.
    • Proficiency with desktop publishing and word processing tools, including Microsoft Word, Microsoft Excel, Microsoft PowerPoint, and familiarity with Windows is required.
We are passionate about our mission to develop high performing products to study genomics in an unprecedented flexibility and to understand biology for the improvement of healthcare. We have built a highly efficient product-driven organization where employees can learn, grow and thrive in a challenging but encouraging environment.  We are committed to scientific integrity, collegiality, honesty, objectivity, and openness.   We offer excellent benefits, which include a 401K plan, competitive health benefits, flexible vacation, and equity incentives. 

We foster an environment such that all people are afforded the freedom to pursue their passions without regard to race, color, religion, national or ethnic origin, gender (including pregnancy), sexual orientation, gender identity or expression, age, disability, veteran status or any other characteristics protected by law.