We are looking for a Validation Engineer for a leading Molecular Diagnostic company in Sunnyvale. You will work as an individual contributor and will be recognized as organization"s expert for computer systems validations. Guides the successful completion of complex computer system projects and often takes on a project leadership role. Applies extensive knowledge of technical principles in defining the validation strategy. Conducts gap analysis for 21 CFR Part11 guidance to software requirements.
ESSENTIAL JOB RESPONSIBILITIES:
* Define test architecture and strategy for complex and integrated systems.
* Coordinate and Participate in requirements development, configuration and change control, and Go/No-Go decisions.
* Write validation plans and reports.
* Create and Execute OQ and PQ protocols as needed
* Guide project team to write quality documents related to software validation and reviews for effectiveness.
* Guide project team's offshore testers and ensures they develop appropriate test scripts based on the projects User and/or Functional requirements.
* Define validation schedule, engage stakeholders to seek agreement on deliverables and responsibilities.
* Coordinate and conduct risk analysis.
* Review and approve quality documents required to maintain the system in validated state.
* A minimum 5 years of software testing experience.
* Must have completed several major computer systems projects (such as ERP, MES) with multiple release cycles and have working knowledge of software development lifecycle in FDA/ISO or other regulated field.
* Must have experience with: Windows environments, Excel macros and/or complex spreadsheets, and SQL or other RDBMS systems.
* Be knowledgeable in QSR and 21 CFR Part 11 regulations.
* Experience in cultivate and maintain contact with key customers, including IT and/or Business; working closely with vendors to complete required tasks.
* Experience in leading resolution efforts when issues are identified and escalate appropriately.
* Experience in proactively identify and assist in prioritizing opportunities to streamline testing and/or quality but still stay compliant.
* Possess excellent analytical and troubleshooting skills, must be self-motivated, willing to learn new concepts, technologies and products quickly.
* Have strong interpersonal, writing and communication skills, as well as dedication to quality software and customer satisfaction.
* BA/BS degree or equivalent work experience in Computer Science or related field or equivalent experience.