| Looking To Hire Computer System Validation (CSV) Engineer Location: North Carolina at North, Virginia, USA |
| Email: dibyaranjan.sahoo@scalable-systems.com |
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From: Dibyaranjan Sahoo, Scalable Systems dibyaranjan.sahoo@scalable-systems.com Reply to: dibyaranjan.sahoo@scalable-systems.com Job Title: Computer System Validation (CSV) Engineer Location: North Carolina | Job Type: Contract Job Summary: Seeking a CSV Engineer to ensure compliance of computerized systems in pharmaceutical, biotech, and medical device industries with FDA, GAMP5, and 21 CFR Part 11 regulations. Key Responsibilities: Develop and execute validation strategies for software and automation systems. Author and review validation documents (IQ, OQ, PQ, risk assessments, test scripts). Perform system impact assessments, data integrity evaluations, and UAT. Collaborate with QA, IT, Manufacturing, and Regulatory teams to ensure compliance. Support regulatory audits and inspections. Qualifications: Bachelors degree in Engineering, Computer Science, or related field. 3-7 years of CSV experience in a regulated industry. Expertise in 21 CFR Part 11, GAMP5, Annex 11, and Data Integrity. Experience validating ERP, MES, LIMS, SCADA, PLC, QMS systems. Preferred: Experience with cloud-based systems validation. Six Sigma/QMS certification is a plus. Best Regards Dibyaranjan Sahoo US IT Recruiter Phone -7327883006 Email ID: dibyaranjan.sahoo@scalable-systems.com Scalable Systems | Inspiring Innovation Big Data | Analytics | Integration | Intelligence www.scalable-systems.com Keywords: quality analyst information technology Idaho Looking To Hire Computer System Validation (CSV) Engineer Location: North Carolina dibyaranjan.sahoo@scalable-systems.com |
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| 05:05 AM 22-Mar-25 |