The Opportunity:

Universal DX is seeking an experienced Senior NGS Automation Engineer to join our growing product development team working on the development and commercialization of Next Generation Sequencing (NGS) assays/products for early detection of colorectal cancer. Reporting to the Director of Automation Development, this role will support a team of US-based Automation Engineers and Assay Development Scientists as well as leverage global collaboration to fully automate Universal DX’s colorectal cancer test for verification and validation testing. Additionally, this role will be a critical contributor to the technology transfer of Universal DX’s colorectal cancer test to a strategic partner site (US-based) for regulatory approval and commercialization.

You will be part of a team that is passionate about developing novel diagnostic tests for the early detection of cancer. As part of the team, you will be in a Company that aims to have a huge positive impact on society by achieving the ambitious purpose of “making cancer a curable disease by detecting it earlier”.

How you’ll contribute:

· Key Contributor in the development of a blood-based early cancer detection test by fully automating manual NGS assay workflows. Collaborate with EU and US based Automation and assay development teams to develop automation solutions and workflows that meet the product requirements of Universal DX’s colorectal cancer test.

· Principal responsibilities of this position include automation projects leadership.

· Lead the development and integration of the automation systems and related software tools.

· Translate user requirements into design specifications for development of high quality, customer focused automated products.

· Define and conduct testing and qualification experiments, IQ/OQ/PQ.

· Support the documentation efforts for equipment validation and operating procedures.

· Lead troubleshooting efforts, analyze data and help drive key process related decisions.

· Work closely with Quality Assurance, Information Technology, and Regulatory groups to ensure the conformance of the automated product with Universal Diagnostics’ regulatory requirements.

What you’ll bring:

· A BS or MS degree Biomedical Engineering or closely related engineering or scientific field, with a minimum of 4 to 6 years of relevant work experience in automating NGS workflows.

· Technical proficiency and experience in automation systems development and integration for the life science industry; especially with robotics and liquid handling systems is required.

· Significant experience developing, optimizing, and troubleshooting complex workflows, preferably using Hamilton Robotic systems.

· Good Project management, organizational and written and verbal communication skills.

· Preparing User Requirement and Testing Procedure, Standard Operating Procedures, and related documentations; and overseeing the functional and validation testing, IQ/OQ/PQ.

· Flexibility and self-initiative required to support several simultaneous projects.

· Biotech, pharmaceutical, Lab automation providers, or clinical-laboratory experience is highly desirable.