Computer System Validation (CSV) Engineer

Hi, We have a position which is suitable to your skillset. Please go through the below JD and let me know your interest. Title : Computer System Validation (CSV) Engineer Location : Raritan, NJ Relevant Experience (in Yrs.): 8+ years Detailed Job Description: • Demonstratable Experience in Computer System Validation (CSV) • Experience in software development processes (SDLC) and software testing life cycle (STLC) • Experience in drafting, reviewing, revising, and maintaining validation documents (CSV), including Compliance Analysis, Compliance Plan, Change Control Document, User & Functional Requirement documents, Risk Assessments (Risk Register), Test (ST/UAT/Regression) Protocol, Test Defect Report, Test Summary Report, Compliance Summary Report, Traceability Matrix, Hypercare Plan, Operation Run Book and other validation & technical documentation. • Experience in drafting Standard Operating Procedures (SOP) and Work Instructions (WI • Strong knowledge of JIRA, Client-ALM, qTest tools • Knowledge of validation & testing in projects implemented using agile methodology • Knowledge about Agile techniques like: User Stories, Continuous Testing, tasks, etc. • Ability to take and understand the commitment to deliver the product on time. • GxP experience is required • Experience of validation support for 21 CFR Part 11 implementation in Pharma industries. • Leading the Tech Writer team for preparing the test cases. • Co-ordinating the testing with the business and automation test teams. • Experience working within a FDA/Other regulated pharma industry. Roles & Responsibilities • Meeting with system users to understand the scope of projects • Participating in business requirement discussions to draft SDLC /CSV /Qualification documents. • Developing validation/qualification/migration/verification strategies for software • Executing validation/qualification/verification/migration strategies per quality assurance SOPs.. • Providing validation/verification/qualification recommendations to stake holders as necessary. • Managing relationships with customers, technical team, quality assurance team, testing team and other stake holders to ensure the validation/ verification/qualification solution delivered to the customer meets expectations. • Ensuring SDLC/CSV/Qualification activities are conducted as planned • Generate, review, and Computerized Systems lifecycle documentation including risk and impact assessments, user requirement specifications, functional specifications, traceability matrices, qualification protocols, validation plans, and validation summary reports etc. • Working towards project deadlines • Communicating findings to technical and non-technical colleagues. • Liaising with project teams in other parts of the world • Leading the validation effort. Generic Managerial Skills, If any • Strong verbal and written communication skills with the ability to liaise with a variety of stakeholders • Must be self-motivated and pro-active • Need to show constant dynamism and able to manage pressure. • Attention to detail • Competent CSV skills • The ability to work in a team and individually • Organizational skills with the capability of working towards tight deadlines • Able to work with demanding customer Thanks & Regards Venkatesh Kundurthi Recruitment Manager || ASCII Group, LLC Office: (248)-476-7600 Ext. 104; Direct: +1 469 663 0625 38345 W. 10 Mile Rd, Ste.#365; Farmington, MI 48335 Email: Venky.K@asciigroup.com Website: www.asciigroup.com