Posted:3 weeks ago|
Platform:
Work from Office
Full Time
Role CSV Engineer Responsibilities Serve as an SME in CSV processes and best practices Develop and execute validation protocols (IQ/OQ/PQ) for computer systems, software applications, and automated processes. Create validation plans, test scripts, and summary reports. Ensure all computer systems comply with FDA regulations, GxP guidelines, and other relevant industry standards (e.g., 21 CFR Part 11). Provide training to staff on CSV processes and regulatory requirements Stay updated on industry best practices, regulatory changes, and advancements in technology related to CSV. Identify opportunities for improving validation processes and procedures. Perform Change Impact Assessments, Risk Assessments, Periodic Reviews . NOTE: Experience in Validation of Lab Systems and Manufacturing Systems is a MUST. Preferred candidate profile 1-3 years of overall experience in computer system validation within the pharmaceutical, biotech, or medical device industry. Strong knowledge of FDA regulations, GxP guidelines, and industry standards (e.g., 21 CFR Part 11, GAMP 5). Proficiency in developing and executing validation protocols and related documentation. Proficient in using validation tools and software. Strong written and verbal communication skills. Education and Trainings Bachelors degree in Biotechnology, Pharmacy, Computer Science, Engineering, Life Sciences, or a related field. Advanced degrees or certifications in validation, quality assurance, or regulatory compliance are a plus.
Emonkglobal
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