Senior Bioinformatics R&D Engineer, Software Validation
- 153 Townsend Street, ca
Provide bioinformatics support for scientific services such as design and implementation of verification and validation strategies for newly developed genomic software, documentation and deliverable preparation in compliance with Quality Systems Regulations and regulatory requirements. Perform software testing, verification, and validation, including "white box" and "black box" testing, test design, test tools and methods, test documentation, test management, test traceability, defect management and tracking. Collaborate with designated personnel to develop various Computer Systems Validation (CSV) documents per FDA guidance (General Principles of Software Validation), including but not limited to: Requirements Specifications, Validation/Test Plan, Testing (across all phases of Development), Integration Test Scripts, Operational/System Test Scripts, Validation Summary Reports. Consult with researchers to analyze validation problems and recommend technology-based solutions. Create novel computational approaches and analytical tools as required by the validation team goals. Confer with systems analysts, engineers, programmers and others to design system applications and obtain information on project limitations and capabilities, performance requirements and interfaces. Define bioinformatics validation test strategy, designing and developing test cases from software requirements, and architecture designs. Ensure Validation documentation is developed and maintained per company policies and procedures.
Minimum Requirements: Master’s degree in Pharmaceutical Science, Drug Regulatory Affairs, Engineering, or related field and 3 years of experience in the job offered or in a validation engineer-related occupation.
Position requires 3 years of experience in the following skills:
1) Utilize knowledge of the Software Validation Lifecycle, related FDA, EU, ISO regulations and guidelines, and specific knowledge of computer validation methodologies and principles to perform computer system validation on a variety of systems;
2) Utilize experience in writing, reviewing and executing computer validation documentation (Validation Plan, Data Migration Plans, Requirement Specifications, IQ, OQ, PQ, RTM, Summary reports) to establish objective evidence that software specifications conform to user needs and intended uses and to confirm data accuracy and integrity in systems so that product safety and effectiveness is ensured;
3) Utilize knowledge of Risk Management, Gap Analysis, Deviation Management and CAPA to best meet compliance objectives and strategy and implement into operational practices;
4) Utilize knowledge of Change Management Process to roll out and prioritize changes efficiently, without negatively impacting customers or agreed-upon service levels and ensure the GxP systems remain in a validated state throughout its life cycle;
5) Utilize knowledge of support in continuous improvement of the organizational software quality system to ensure regulatory compliance, audit readiness and to assure state-of-the-art software development methods