Genomic Health, Inc.
Genomic Health, Inc., a life science company founded in August of 2000 and located in Redwood City, California, conducts sophisticated genomic research to develop clinically validated molecular diagnostics, which provide individualized information on the likelihood of disease recurrence and response to certain types of therapy. These diagnostic technologies generate information that healthcare providers and patients can use in making treatment decisions.

Lead Computer Systems Validation
Job ID:  1341

Overview

As a member of the Software Validation and Quality Assurance (SV&QA) team in the Regulatory and Quality Assurance group, the Lead Engineer, Computer System Validation for RA /QA will play a strong role in the implementation of the company's policy and procedures for the validation of computer systems, analytical software (SAS), automated processes, equipment and instrumentation. The Lead Engineer's involvement in validations preformed throughout the company may include: providing consultation in formulating the validation strategy, preparing plans, developing or reviewing validation deliverables, training, handling of variances, and preparing or reviewing validation reports. In addition, the Lead Engineer may directly perform validations of systems, especially those used by Quality Assurance.

Genomic Health is seeking a Lead validation expert that can guide members of various departments in a "critical thinking approach" to the validation of computer systems, processes, equipment and instrumentation. We seek to identify the most meaningful set of confidence-building activities to apply during a validation. Critical thinking results in a validation solution that establishes compliance, ensures that the software is safe for use, results in documented evidence that is deemed appropriate and adequate by reviewers, and results in a scenario where individuals performing the validation work feel that the effort was least burdensome and value-added.

The validations which this Lead Engineer must be able to support include systems that create, modify, maintain, archive, retrieve, transmit, or analyze data used in production and the quality system. Examples include off-the-shelf and custom software used to automate production, off-the-shelf software used in the quality system (e.g., document control, calibration, etc.), custom software used in production, tools used in the development of software, and custom programs used for statistical analyses in pre-clinical and clinical investigations.

This individual will have a broad grounding in quality assurance in FDA regulated industries. This grounding will provide a foundation for understanding when validation is needed and the risks to compliance and quality records from a system failure.

Responsibilities

• Provide guidance on the application of the GHI computer system validation policies and procedures
• Train individuals on policy, procedures, and validation activities
• Provide guidance to project teams on the validation deliverables for projects, including, risk assessments, validation planning, applying the GHI risk based approach, the preparation of deliverables, the execution of protocols / testing, and the preparation of reports
• Take a "critical thinking approach" to identify the most meaningful set of confidence-building activities to apply during a validation.
• Take a risk-based approach in matters related to validation. Facilitate risk assessment sessions for items / computer systems to be validated
• Manage contract validation resources
• Participate on system implementation teams to ensure that validation is appropriately integrated into the implementation
• Review and approve validation documentation in accordance with GHI policies
• Conduct validations
• Audit validations performed by other departments
• Participate in audits of computerized system suppliers and software vendors
• Evaluate change requests for validated systems and ensure that appropriate validation is performed in regard to the change

• In-depth knowledge of validation regulations, guidance documents, industry standards, and methods
• Knowledge of software validation methods for custom, configured, and off-the-shelf systems
• Knowledge of lab equipment and instrumentation, and validation methods for such items
• Demonstrated ability to influence project teams and individuals on computer validation matters
• Broad knowledge of quality system regulations, such as QSRs, GCPs, ISO 13485, ISO 14971, and Global Harmonization Task Force guidance
• Excellent verbal and written communication skills
Qualifications

• 10+ years experience in validation in the medical device, diagnostics, or pharmaceutical industry with emphasis on computer system validation
• Demonstrated experience in applying risk-based and critical thinking approaches to computer system validations
• Demonstrated track record of planning, executing and managing major validation projects in an FDA regulated environment and driving projects to closure
• Experience with Laboratory Information Management Systems, instrument software, and process automation systems a plus.
• Experience in any of the following also is a plus: experience in managing computer system validation contractors, software development / quality assurance, biomedical research and development, and establishing and using quality assurance systems

For immediate consideration, please apply directly to our website at: https://jobs-genomichealth.icims.com/genomichealth_jobs/jobs/candidate/job.jsp?jobid=1341&mode=view