| opening for Validation & CSV Lead Engineer at Remote, Remote, USA |
| Email: [email protected] |
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http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=2119999&uid= From: Hari Prasath Asokan, kk software [email protected] Reply to: [email protected] Hi, This is Hari from kk associates, Below Position is Immediate Position from the Client Kindly share Suitable resumes to [email protected]. Validation & CSV Lead Engineer Location: Puerto Rico, TX Hire Type: Contract Job Description: Role name: Engineer Role Description: Computer System Validation (CSV), Validation, IQ, OQ, PQ, FAT, SAT Competencies: EIS : Medical Device & Regulations Experience (Years): 4-6 Essential Skills: Validation & CSV Lead EngineerMinimum of 5 Yr exp leading the validation of a major capital automation projects.1. Validation and Compliance Knowledge GxP (Good Practice) Guidelines: Familiarity with GxP guidelines such as Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Good Clinical Practice (GCP). FDA 21 CFR Part 11: Understanding of the regulatory requirements related to electronic records and signatures. ISO Standards: Familiarity with ISO 9001, ISO 13485 (for medical devices), and ISO/IEC 27001 (for information security). Validation Lifecycle Management: Knowledge of the entire lifecycle from planning, execution, and reporting, including IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification).2. Computer System Validation (CSV) Expertise CSV Methodologies: Strong understanding of CSV processes, including risk-based approach, qualification testing, validation protocols, and traceability matrix development. System Integration & Interface Testing: Skills in validating interfaces between different systems, including ensuring data integrity during integration. Software Testing: Experience with software test methodologies (e.g., functional, performance, stress testing). Documentation & Reporting: Creating and maintaining validation documentation such as protocols, reports, and deviations. Proficiency in technical writing is key.3. SCADA, SAP4. Nice to have: Work experience in the medical device industry Keywords: Alaska Texas opening for Validation & CSV Lead Engineer [email protected] http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=2119999&uid= |
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| 09:00 PM 28-Jan-25 |