| Opportunity for Mid-Level CSV Engineer Apply Today! at Remote, Remote, USA |
| Email: tarun.manukonda@srsconsultinginc.com |
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https://shorturl.at/zCvmO https://jobs.nvoids.com/job_details.jsp?id=2271050&uid= From: Manukonda Tarun Kumar, SRS CONSULTING INC. tarun.manukonda@srsconsultinginc.com Reply to: tarun.manukonda@srsconsultinginc.com Hello, "Greetings from SRS Business solutions". I am Manukonda Tarun Kumar, We have an immediate opening for the below position with one of our premium clients. If interested, Can you please send me an updated resume, employer details & contact Details to discuss about the rate and role. Title: CSV Engineer Location: Bay area, CA - Onsite from Day 1 - 5days / Week Duration: 12+ Months contract Job Type: Contract Job Summary: We are looking for a Mid-Level CSV Engineer to ensure compliance with regulatory standards by validating computer systems used in pharmaceutical, biotech, or medical device industries. The ideal candidate will have experience in system validation, GxP compliance, and documentation as per FDA, EU, and other global regulatory guidelines. Key Responsibilities: Develop and execute Computer System Validation (CSV) plans, protocols, and reports (IQ, OQ, PQ). Ensure compliance with 21 CFR Part 11, GAMP 5, and other regulatory requirements. Perform risk assessments and gap analysis for computerized systems. Develop and maintain validation documentation, including Validation Master Plans (VMP), User Requirements Specifications (URS), and Test Scripts. Work closely with IT, Quality Assurance (QA), and business teams to ensure validation requirements are met. Support audits and inspections by providing necessary validation documentation. Conduct periodic system reviews and revalidation as needed. Troubleshoot validation issues and recommend corrective and preventive actions (CAPAs). Required Skills & Qualifications: Bachelors degree in Computer Science, Life Sciences, Engineering, or a related field. 3-5 years of experience in Computer System Validation (CSV) within pharmaceutical, biotech, or medical device industries. Strong knowledge of GxP, 21 CFR Part 11, EU Annex 11, GAMP 5, and SDLC methodologies. Hands-on experience with validation documentation, protocols, and testing. Familiarity with ERP, LIMS, MES, QMS, or other regulated software systems. Experience in handling regulatory audits and compliance requirements. Excellent documentation, communication, and problem-solving skills. Preferred Qualifications: Experience with cloud-based validation (AWS, Azure, GxP SaaS solutions). Knowledge of data integrity principles and ALCOA+ guidelines. Experience in CSV tools like ValGenesis, MasterControl, or similar platforms. Certification in CSV, GAMP 5, or Quality Assurance is a plus. Compensation & Benefits: Competitive salary based on experience Health insurance & benefits Professional development and training opportunities Hybrid/Remote work options availabl Regards Tarun Manukonds Keywords: quality analyst access management information technology California Opportunity for Mid-Level CSV Engineer Apply Today! tarun.manukonda@srsconsultinginc.com https://shorturl.at/zCvmO https://jobs.nvoids.com/job_details.jsp?id=2271050&uid= |
| tarun.manukonda@srsconsultinginc.com View All |
| 03:34 AM 20-Mar-25 |