| Job shared Computer System Validation (CSV) Engineer with you at Remote, Remote, USA |
| Email: [email protected] |
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From: Nancy, Scalable Systems inc [email protected] Reply to: [email protected] Hi, Hope youre doing great. We do have urgent opening for below role. If youre looking for new role, please share updated resume. Job Title :- C omputer System Validation (CSV) Engineer Location :- North Carolina n Duration- 12+ months Implementation- TCS Job Description :- 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 Nancy Jaswal [email protected] https://www.linkedin.com/in/nancy-jaswal-b7255b199/ [www.scalable-systems.com] Scalable Systems | [www.scalable-systems.com] Inspiring Innovation Big Data | Analytics | Integration | Intelligence www.scalable-systems.com Keywords: cprogramm quality analyst information technology Job shared Computer System Validation (CSV) Engineer with you [email protected] https://jobs.nvoids.com/job_details.jsp?id=2278991 |
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| 04:09 AM 22-Mar-25 |