Sr Process Engineer (15-PD-045)

Organization
Complete Genomics, Inc.
Job Location
San Jose, CA 95131
Benefits

Complete Genomics’ Reward Package is made up of three parts:

  • Base Compensation
  • Incentive-based compensation (bonus/equity programs)
  • Benefits

Complete Genomics offers its eligible employees and their dependents (including domestic partners) a comprehensive and competitive benefits package. Complete Genomics contributes to the benefits package.

  • Medical, Dental and Vision Coverage
  • Life and AD&D Insurance
  • Long-term and Short-term Disability Insurance
  • Voluntary Life and AD&D Insurance
  • Voluntary Long Term Care Insurance
  • Flexible Spending Accounts (FSA)
  • Domestic Partner Benefits
  • Commuter Program
  • Employee Assistance Program
  • 401(k) Retirement Plan
  • 20 PTO days and 11 holidays per year

This benefits-at-a-glance has been designed to give you an overview of the Complete Genomics Reward Package. It does not, however, attempt to explain all the details, provisions, restrictions and exclusions of the package. The Company reserves the right to change or terminate any part of this package at any time.

Job Description

Job Title:  Sr Process Engineer

Reports To:  Director, Sequencing Operations and Reagent Manufacturing

Department:  Reagent Manufacturing

Location:   Mountain View, CA transitioning to San Jose, CA

 

Job Summary

Complete Genomics is currently seeking a highly motivated Senior Process Engineer to join its Operations team.  The role will be in support of the Reagent Manufacturing, Filling and Packaging departments, contributing to the commercialization of consumables for our next generation DNA sequencing platform.  This exciting position provides an opportunity to contribute to CGI’s goal of improving human health by providing researchers and clinicians with the core technology and commercial systems to understand, prevent, diagnose, and treat diseases and conditions.                                                                        

Major Duties and Responsibilities

  • Lead product scale-up, process optimization, technology transfer, and equipment/process validation activities, as related to the Formulation, Filling, Labeling, and Packaging of CGI’s consumable Reagents.  Will help to develop and qualify robust, high quality, and cost effective processes for manufacturing of these products.
  • Responsible for process and equipment validation, including developing protocols, execution, and generating reports. 
  • Will be responsible for leading and/or contributing in cross-functional teams consisting of Manufacturing, R&D, Quality, Procurement, Equipment Services, Hardware Engineering and others.  Perform project management functions to effectively drive results, manage project schedules, and communicate project status, experimental plans and results.  Position may require interaction with other global manufacturing sites or contract manufacturing partners.
  • Drive implementation through manufacturing, including setting up infrastructure, production documentation, and training on new processes and equipment.
  • Ensure manufacturability of operations as it pertains to the utilization of staffing, facility (layout, etc.), materials, and equipment.  
  • Work with development and hardware engineers to establish equipment/instrumentation requirements and specifications.  Interfaces with vendors on procurement, installation, maintenance, etc.
  • Responsible for ongoing technical support of sustaining operations, including troubleshooting of equipment and process problems. 
  • Generate various documentation such as process flow diagrams, operating procedures, work instructions, equipment SOP’s, validation plans, reports and protocols. 
  • Conform to requirements for Design Control.  Perform design and process risk assessments, such as pFMEA.  Conduct design reviews. 
  • Apply working knowledge of Lean/Six Sigma principles in manufacturing, utilizing various tools (VSM, 5S, Kaizen, Visual Controls, etc.) to drive Continuous Improvement efforts.  Develop metrics and controls to drive manufacturing improvements in the areas of cost, quality, yield, safety, and TAT.
  • May be required to perform other related duties as required and/or assigned.
Requirements
  • Bachelor's degree in in Bioengineering, Chemical Engineering, Industrial Engineering or related field with a minimum of 6 years of experience; or Master’s degree with a minimum of 4 years of experience; or equivalent combination of education and experience. 
  • 4+ years of industrial experience in the commercialization, scale up, transfer, and validation of molecular biology based consumables.  Familiarity with the formulation, handling and processing of oligo and enzyme based reagents.
  • Strong practical experience in the filling, labeling and packaging of consumable products, as well as familiarity working in controlled manufacturing environments and under aseptic conditions. 
  • Background in automation, robotics, filling, packaging and labeling equipment a must.
  • Experience working in an ISO13485 or cGMP regulated environment, either dealing with medical devices or biopharmaceutical products highly desirable.
  • Expertise in the optimization of manufacturing processes through the use of Lean/Six Sigma tools and principles, statistics and data analysis methodologies. Green or black belt highly desirable, with strong understanding of Operational Excellence concepts.
  • Experienced with the systems used in production environments, such as the laboratory information management systems (LIMS) and business systems (Oracle ERP).
  • Strong project management and organizational skills, with great attention to detail.  Ability to handle multiple projects at once of varying scope and complexity.
  • Creative thinker, with strong analytical and problem solving skills.
  • Excellent interpersonal skills, with demonstrated ability to effectively collaborate with and influence others across all levels of the organization.
  • Demonstrated strength working with cross-functional partners in a rapidly changing and challenging production environment. 
  • Strong working knowledge of Design Control requirements and Quality Systems.
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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