| CSV Engineer, Remote in NC at Remote, Remote, USA |
| Email: g.nain@sibitalent.com |
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https://shorturl.at/zCvmO https://jobs.nvoids.com/job_details.jsp?id=2312259&uid= From: Gaurav Nain, sibitalent.com g.nain@sibitalent.com Reply to: g.nain@sibitalent.com Job Title:- CSV Engineer Visa :: USC/GC Location :: Remote in NC Experience :: 8+ years Note:- need local and strong candidate Need candidate from NC Description:- Company Description: Our client is a global biotech drug manufacturer located in the USA and Germany and is currently expanding its manufacturing facilities. The manufacturing sites are state-of-the-art aseptic processing facilities equipped with advanced technology and equipment to ensure the safety and quality of the products manufactured following USA and Europe regulations. They have the ability to produce a wide range of biologics, including monoclonal antibodies, recombinant proteins, and other complex therapies. Position Description: The CSV Engineer will be responsible for performing software installation, configuration, and computer system validations within the client USA and Europe manufacturing sites. The CSV Engineer will work to ensure all systems operate in full compliance with applicable USA and European regulations and maintain consistent functionality throughout their operational life. Responsibilities: Perform computer system validation, particularly for BMRAM, ServiceNow systems, and Citrix/AD Migration Author and execute computer system validation and qualification documents, including defining test cases and writing test scripts. Manage system administration and access controls. Collaborate with internal functions and external vendors regarding qualification and validation issues. Define and implement IT Infrastructure strategies, including backup procedures. Manage system upgrades and ensure smooth transitions. Conduct periodic reviews and system audit trail assessments. Create and maintain equipment operation procedures and participate in data integrity initiatives related to computer systems. Qualifications: Proven experience in computer system validation (CSV). Strong knowledge of regulatory requirements (e.g., USA FDA, 21 CFR Part 11, GxP and the EMA). Experience writing and executing validation documentation, including test cases and test scripts. Familiarity with system administration, access management, and security protocols. Knowledge of IT infrastructure and backup strategy development. Ability to manage system upgrades and conduct periodic system reviews and audits. Strong understanding of data integrity principles and secure software configuration practices. Knowledge of Veeva application. Excelent presentation skills and English speaking and writing is a must. Education & Certifications: Eight years of experience in IT and GxP compliance performing similar tasks and a bachelor's degree in engineering (highly desirable), computer science, or a related field Keywords: active directory information technology green card North Carolina CSV Engineer, Remote in NC g.nain@sibitalent.com https://shorturl.at/zCvmO https://jobs.nvoids.com/job_details.jsp?id=2312259&uid= |
| g.nain@sibitalent.com View All |
| 08:19 PM 03-Apr-25 |