Sr. Development Process Engineer

Organization
Complete Genomics, Inc.
Job Location
Mountain View, CA 94043
Job Description

ob Title:  Sr. Development Process Engineer

Reports To:  Principal Technology Transfer Scientist, Reagents

Department:  Biochem Systems Integration

Job Summary

 

We are looking for a motivated process engineer to join the Complete Genomics reagents team in supporting the latest generation of our proprietary DNA sequencing platform.

The successful candidate will develop and transfer to production the processes, equipment and infrastructure required for the large scale manufacture and kitting of molecular biology reagents for next generation sequencing applications.                    

Major Duties and Responsibilities

 

  • Develop, and transfer to production processes for the formulation, filling, plating and packaging of oligo and enzyme based reagents, buffers and other critical components. 
  • Work closely with manufacturing to automate, scale-up and transfer equipment and processes to new large scale facility.
  • Design and execute test plans for the qualification of new automated systems. Conduct design and process FMEA’s.  In collaboration with QA and manufacturing, write verification and validation protocols.  Lead the execution of these protocols.
  • Create detailed process flow diagrams and work with manufacturing to identify and source required manufacturing equipment.
  • Setup infrastructure in new ERP and MES systems (Part Numbers, Bills of Material, workflows etc.).  Write test plans/reports, SOP’s and specification documents.
  • Collaborate with the Biochemistry Automation team to test scripts, and use cases for automated high throughput Library Prep reagent manufacture
  • Work on cross-functional teams consisting of Manufacturing, R&D, QA and others.  Effectively communicate experimental plans and results.
  • Perform other work related duties as assigned.
Requirements

Minimum Qualifications

 

  • Bachelor's degree in Process Engineering, Biotechnology Engineering, Chemical Engineering or related field with a minimum 6 years of industrial experience in the development, scale-up and transfer of manufacturing processes for oligo and enzyme based molecular biology reagents; or equivalent combination of education and experience. 
  • Experienced sourcing and qualifying manufacturing equipment for the formulation, filling, labeling and packaging of consumables.
  • Expertise writing and executing verification and validation protocols.
  • Expertise developing and testing the automated liquid handling of molecular biology reagents.
  • Expertise in the optimization of manufacturing processes through the use of statistics and data analysis tools.
  • Experienced with the systems used in production environments, such as the use of laboratory information management systems (LIMS/MES) and business systems (ERP).
  • Strong analytical, organizational, and planning skills, with great attention to detail. Excellent verbal and written communication skills.  Demonstrated strength working with cross-functional partners in a rapidly changing environment. 
  • Experience in a 13485 or GMP environment.
  • Experience working in a clinical laboratory is a plus.
About Our Organization

Complete Genomics is a leader in accurate whole human genomic sequencing based in Mountain View, California. Using its proprietary sequencing instruments, chemistry, and software, the company has sequenced more than 20,000 whole human genomes over the past three years. The company’s mission is to improve human health by providing researchers and clinicians with the core technology and commercial systems to understand, prevent, diagnose, and treat diseases and conditions. The company spans multiple specialties: genomics, biochemistry, molecular biology, bioinformatics, software, hardware engineering, semiconductors, operations, research and development, and others.

Complete Genomics is a U.S. subsidiary of BGI, the world’s largest genomics services company headquartered in Shenzhen, China. BGI provides comprehensive sequencing and bioinformatics services for commercial science, medical, agricultural and environmental applications. BGI is recognized globally as an innovator for conducting collaborative projects globally with leading research institutions.

Through the dedication and hard work of our employees, Complete is working towards a lasting impact in the genomics and health fields. Employees live by our company values which focus on our customers, innovation, commitment to our word, teamwork, timely decisions, and operational excellence. Complete is an inclusive, collaborative environment with fun socials and company events, regular communication forums, and community program involvement. We are looking for people who thrive in a challenging, fast-paced environment, who are team oriented, self-motivated, and committed to contributing to the success of our company.

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