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Senior Validation and Configuration Engineer (Process Eng.)

Company: Genomic Health
Location: Redwood City
Posted on: March 14, 2018

Job Description:


Genomic Health is seeking an experienced, collaborative, and enthusiastic engineer to promote and propagate best practices in system validation, configuration management, and the design, implementation, and management of software-based workflows within key software applications including, for example, Quality Management System software. As the Senior Validation and Configuration Engineer, you will play an influential role in leading efforts to configure, design, and deliver sustainable workflows and software solutions that set a foundation of quality and contribute to achieving corporate objectives. You will partner closely with Quality Assurance to pilot new software- and automation-development processes that are compliant with applicable national and international regulations and standards. You will also ensure that these software and automation-development processes, as used by Process and Service Engineering, employ best practices.

You will successfully lead, manage, and/or contribute to cross-functional teams with an initial focus on system validation and deliver standardized workflows for configuration management. You will also be responsible for leading and coordinating activities for design, development, testing, deployment, documentation, and training for the configuration management process. You will be expected to apply and advocate best practices in system validation and configuration management, train the appropriate team members, and identify opportunities for continuous improvement. You will report to the Manager of Process Development and Automation in the Process Engineering group.


- Lead adoption of streamlined processes for change control and system validation within Service and Process Engineering, in
collaboration with Quality Assurance and championing best principles.
- Provide leadership in efficient, effective configuration management for automated laboratory instrumentation, including
implementation and administration of configuration management software, continuous improvement of the associated workflows for
this purpose, and authoring procedures and records.
- Lead and contribute to validation of specific computer-based systems used within Operations, such as software used to operate
laboratory instrumentation, in collaboration with Quality Assurance, Non-Clinical Biostatistics, R&D, and Information Technology and
championing best principles.
- Lead cross-functional teams, collaborating with Quality Assurance, end-user groups, and Information Technology and other groups as
required, to design, configure, validate, implement, and manage scalable and compliant software -based workflows and solutions
which directly impact sample processing and supporting processes/workflows.
- Author, review, and provide training as required on procedures and records for validation of software, equipment, facilities, and
processes, such as requirements documents, traceability matrices, validation plans, design records, etc.
- Train others in the design, configuration, deployment, use and/or maintenance of software solutions and software-based workflows
including, for example, management of hardware and software configurations for laboratory automation equipment.
- Train others in design and development procedures applicable to development of scripting software, web methods, and other
software components used in automated sample processing.
- Contribute to cross-functional efforts that ensure compliance with ISO13485, ISO15189, ISO 62304, and other domestic and
international regulations and standards.
- Champion best principles in training and software development, leading by example.
- Configure and administer GHI's electronic Quality Management System (eQMS), including configuration and deployment of workflows
within the eQMS, as needed.
- Transfer skills and knowledge to designated personnel with differing backgrounds and training.
- Measure current processes and identify areas for improvement.
- Other responsibilities as assigned in support of Operations.


- A BS degree in engineering or science, preferably in bioengineering, biomedical engineering, chemical engineering, computer science, or a closely-related discipline and a minimum of 8 years of related experience. An MS with
at least 5 years or a PhD with at least 3 years of related work experience will also be considered.
- Three or more years of experience working in medical devices, in vitro devices, pharmaceuticals or other highly regulated field
- Demonstrated ability to configure, design, and implement software solutions, particularly those related to automated laboratory
instruments, in compliance with ISO13485, ISO15389 or other similar standards
- Demonstrated ability to lead cross-functional teams through the design, testing, and implementation of software-based workflows
- Demonstrated ability to lead process development, improvement, and troubleshooting projects
- Experience partnering with Quality Assurance and Information Technology to build compliant workflows, processes, and procedures
- Experience integrating automated instruments with Information Management Systems (IMS)
- Experience with selecting, configuring and deploying software processes and tools dealing with change control and configuration
- Skilled in verifying and validating software solutions in a regulated environment
- Skilled in gathering software and process requirements
- Skilled in identifying root cause and complex problem solving
- Skilled in training end-users and support personnel
- Knowledge of software design control and validation
- Able to communicate effectively with management, team members, stakeholders, project sponsors, outside consultants and vendors,
internal and external customers
- Ability to work as part of a cross-functional team according to an established timeline

- Experience with Team Foundation Server or Jira software
- Experience with Perforce, Visual Source Safe, or other software for source control
- Experience with CATSWeb software or other eQMS platforms
- Experience with standard molecular biology techniques for isolation, purification, quantitation, and amplification of nucleic acids
- Experience programming automated laboratory instruments and/or systems, such as liquid handling robotics
- Five or more years of experience working in medical devices, in vitro devices, pharmaceuticals or other highly regulated field
- Knowledge of TECAN EVOWare and/or Hamilton Venus scripting language
- Experience writing vb scripts, web methods, and/or microapps
- Experience in GAMP
- Familiarity with CAP and/or CLIA regulations
- Track record of project success per agreed-upon timelines
- Project management skills or certification

Keywords: Genomic Health, San Francisco, Senior Validation and Configuration Engineer (Process Eng.), Engineering, Redwood City, California

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