Senior Process Validation Engineer (Instrumentation & Software)

Genomic Health, Inc. Redwood City , CA 94063

Posted 3 months ago

Overview:

POSITION SUMMARY:

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.

RESPONSIBILITIES / DUTIES:

  • 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.

QUALIFICATIONS:

REQUIRED

  • 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.

DESIRED

  • 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

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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.


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Senior Process Validation Engineer (Instrumentation & Software)

Genomic Health, Inc.