Senior Process Validation Engineer (Instrumentation & Software)

Genomic Health, Inc. Redwood City , CA 94063

Posted 3 months ago



Reporting to the Director of Process Validation, this Senior Process Validation Engineer will provide leadership and expertise in validation and configuration management for Genomic Health's state of the art Clinical Laboratory and manufacturing facility for IVD consumables.

The successful candidate will play an influential and leading role for ensuring that processes and systems are installed, operate, and perform as specified; all commercial manufacturing processes are capable of reliably and repeatedly producing products of the required quality. This position will also partner closely with Engineering and Quality Assurance to pilot new software- and automation-development processes that are compliant with the applicable regulations and standards. He/she will apply and advocate best practices in validation and configuration management, train the appropriate team members, and identify opportunities for continuous improvement.


  • Lead validation of process, equipment, computer system, and software in LDT and manufacture.

  • Provide leadership in effective configuration management for laboratory instrumentation and software.

  • Implement configuration management software and authoring procedures and records.

  • Lead adoption of streamlined processes for change control in collaboration with Quality Assurance and championing best principles.

  • Author risk assessments, user requirements specification, system requirements, validation plans/protocols/reports, IO/OQ/PQs, and traceability matrices for processes, systems, and software validation.

  • Execute manual tests. Analyze data, prepare reports summarizing results and statistics.

  • Develop and communicate expectations for quality performance, continuous improvement, process controls infrastructure for critical sustaining parts and new products.

  • Operate a variety of laboratory instrumentation and simulators to perform integration testing and functionality testing with new hardware and software.

  • Provide consultation to other departments performing validation activities

  • Train others in the configuration, deployment, use and/or maintenance of software solutions and software-based workflows.

  • 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.



  • A BS degree in engineering or science (preferably in bioengineering, biomedical engineering, chemical engineering, computer science, information systems, software engineering or a closely related discipline) and a minimum of 8 years of related experience. An MS with at least 5 years or a Ph.D. with at least 3 years of related work experience will also be considered.

  • Minimum 3+ years of experience in verifying and validating software solutions in a regulated environment (medical devices/IVD or pharmaceuticals).

  • Knowledge of software design control and validation, particularly those related to automated laboratory instruments, in compliance with ISO13485, ISO 62304, ISO15389 or other similar standards.

  • Able to apply a risk-based approach to testing strategies, for a more efficient and targeted validation effort.

  • 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).

  • Skilled in generating audit-ready required documentation.

  • Skilled in gathering software and process requirements.

  • Skilled in identifying root cause and complex problem-solving.

  • Excellent interpersonal, written, and verbal communication skills.

  • Ability to work as part of a cross-functional team according to an established timeline.


  • Experience programming automated laboratory instruments and/or systems, such as liquid handling robotics

  • Experience with standard molecular biology techniques for purification, quantitation, and amplification of nucleic acids

  • Experience in system and software development and testing

  • Five or more years of experience working in medical devices/IVD

  • Knowledge of TECAN EVOWare and/or Hamilton Venus scripting language

  • Experience in 21 CFR Part 11, GAMP5 and data integrity

  • Familiarity with CAP and/or CLIA regulations

  • Project management skills or certification


Reporting to the Director of Process Validation, this Senior Process Validation Engineer will provide leadership and expertise in validation and configuration management for Genomic Health's state of the art Clinical Laboratory and manufacturing facility for IVD consumables.

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Senior UI Software Engineer


Posted 7 days ago

VIEW JOBS 10/17/2019 12:00:00 AM 2020-01-15T00:00 Design, develop, troubleshoot and debug software programs for databases, applications, tools, networks etc. As a member of the software engineering division, you will assist in defining and developing software for tasks associated with the developing, debugging or designing of software applications or operating systems. Provide technical leadership to other software developers. Specify, design and implement modest changes to existing software architecture to meet changing needs. Duties and tasks are varied and complex needing independent judgment. Fully competent in own area of expertise. May have project lead role and or supervise lower level personnel. BS or MS degree or equivalent experience relevant to functional area. 4 years of software engineering or related experience. Oracle is an Affirmative Action-Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability, protected veterans status, age, or any other characteristic protected by law. The Oracle Cloud Infrastructure (OCI) team can provide you the opportunity to build and operate a suite of massive scale, integrated cloud services in a broadly distributed, multi-tenant cloud environment. OCI is committed to providing the best in cloud products that meet the needs of our customers who are tackling some of the world's biggest challenges. We offer unique opportunities for hands-on engineers with the expertise and passion to solve difficult problems in distributed highly available services and virtualized infrastructure. At every level, our engineers have a significant technical and business impact designing and building innovative new systems to power our customer's business critical applications. Identity Cloud Service (IDCS) is a strategic focus for Oracle Cloud Infrastructure. IDCS provides an innovative, fully integrated service that delivers all the core identity and access management capabilities through a multi-tenant Cloud platform. Reference link: Who are we looking for? We are seeking highly accomplished web application software developers who can be part of the IDCS software development team. If you are motivated and have the desire to build intuitive User Interfaces, passionate about delighting customers with exceptional user experiences, then IDCS is the right place for you. Members of our team currently perform tasks such as the following: * Design and develop new features based on Cloud UI technologies in an agile fashion. * Develop designs geared towards massive scalability, and code the core elements of those designs to make adoption faster. * Triage bugs and perform root cause analysis and fix them * Work with UX, PM and senior engineers to collaborate on UX design, with a keen eye for usability. * Create and maintain close relationships with other UI developers across IDCS to collaborate, contribute and align on best UI practices * Implement test strategies, design automation frameworks, write unit/functional tests to drive up code coverage and automation metrics. * Present technical solutions to complex problems clearly and succinctly. Minimum Qualifications * BS/MS and 4 years of professional software engineering experience * Necessary programming languages, programs, tools, etc: * Strong JavaScript, HTML5, CSS, JSON and AJAX * Experience with modern front end frameworks/ libraries Preferred Qualifications * Experience with building and managing the Web interface development for large enterprise products or services offered in cloud. * Expert level knowledge in JavaScript, HTML5, CSS, JSON and AJAX. * Experience in Javascript frameworks like Knockout, AngularJS, ReactJS or Oracle JET * Experience in automated testing including unit and functional testing with frameworks such as Selenium, Mocha and QUnit. * Working knowledge in NodeJS * Experience with git/GitHub * Proven track record of successfully delivering scalable, high performing and intuitive UI's. * Excellent interpersonal and communication skills. * Experienced in training and mentoring team member in best practices, solving deep technical problems and continuously contribute to innovation. Oracle is an Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability and protected veterans status or any other characteristic protected by law. Oracle Redwood City CA

Senior Process Validation Engineer (Instrumentation & Software)

Genomic Health, Inc.