Software Validation Lead
Resolution Bioscience is seeking an experienced Software Validation Lead to join our fast-growing team. The primary role of this position will focus on Validation of our genomics analysis software system and LIMS for both the US and international markets. You will ensure the software meets global quality and regulatory requirements. This software is an essential component of Resolution Bioscience's "liquid biopsy" cancer diagnostic platform. Your contributions will help us complete our transition from on-premises to; ready our software systems to meet important regulatory milestones; scale to meet 10x increase in patient/tests delivered over the next year; and add significant new capabilities.
Responsibilities for the Sr. Software Validation Engineer include:
-Manage validation/qualifications for Liquid Biopsy NGS pipeline and related software
-Design, create, execute and approve Software Validation protocols for CFR 21 Part 11 Compliance - includes full lifecycle focused on the creation of software requirements, hazard analysis, testing and Validation
-Communicate cross-functionally with engineering departments and perform ongoing research to assure that all devices are maintained for quality compliance.
-Proven capabilities in creating validation documentation, including GxP Assessments, Validation Plans, Risk Assessments, Requirements/Design/Functional Specifications, IQ/OQ/PQ Protocols, Reports, Traceability Matrix, and Standard Operating Procedures
-Experience with systems including (but not limited to) on-premise and cloud solutions such as, LIMS, Veeva, Clinical Databases, EDC; as well as networks/infrastructure and hardware qualification
-Demonstrated experience planning and scheduling validation and validation lifecycle deliverables, test execution, and deviation management
-Share best practices, industry knowledge, and personal expertise to educate both clients and fellow consultants, in formal and ad hoc settings
Qualifications for the Software Validation Lead include:
-BS Degree in Software Engineering, Biomedical Engineering, or Computer Science. In place of degree, 10 years of applicable work experience and professional certifications may be considered.
-Minimum of 7 years Software Development or Software Quality Engineering experience within an FDA-Regulated, --Medical Device, Pharmaceutical, Biotech, or other regulated industry. CFR 21 Part 11 and IEC 62304
-Advanced knowledge of IT systems, preferably in the Engineering environments.
-Experience with managing Virtual Machine systems and basic server administration.
-Experience with any of the following Software Languages: C++, C#, Java, Visual Basic and HTML
Resolution Bioscience is an EEO employer. Salary DOE with a competitive benefit offering.
Please apply at: https://resbio.bamboohr.com/jobs/view.php?id=14