| CSV Validation Lead Engineer at Remote, Remote, USA |
| Email: pradeep.sharma@scalable-systems.com |
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https://jobs.nvoids.com/job_details.jsp?id=2118762&uid= From: Pradeep, Scalable Systems pradeep.sharma@scalable-systems.com Reply to: pradeep.sharma@scalable-systems.com Hi, Greetings of the day I wanted to connect with you about an exciting role that aligns with your expertise and could be a fantastic start to your new year. Please find the job details below: Job Title: Validation & CSV Lead Engineer Location: Puerto Rico, TX (Work from Office) Duration: Long Term Contract Roles & Responsibilities: Minimum 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 Thanks & Regards, Pradeep Sharma Email: pradeep.sharma@scalable-systems.com "Scalable Systems is an Equal Opportunity Employer. We are committed to creating an inclusive environment for all employees and do not discriminate based on race, color, religion, sex, national origin, age, disability, or any other legally protected status." Keywords: Texas CSV Validation Lead Engineer pradeep.sharma@scalable-systems.com https://jobs.nvoids.com/job_details.jsp?id=2118762&uid= |
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| 07:13 PM 28-Jan-25 |