Role Description
Serve as an SME in CSV processes and best practices
Manage complex validation projects as an SME
Provide inputs and guidance on the Validation approach. Assist in developing/modifying the validation processes and procedures
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 prospects for improving validation processes and procedures.

Experience
10+ years of overall experience in computer system validation within the pharmaceutical, biotech, or medical device industry.




Experience in developing/modifying procedures for CSV
Experience with validation of Computerized Systems (Process control systems, Laboratory systems, and Process equipment), ERP systems, LIMS, MES, or other GxP systems.
Solid 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.
Solid written and verbal communication skills.

Education and Trainings
Bachelor’s 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.

📌 Consultant Bangalore East (Attibele)
🏢 eMonkGlobal
📍 Attibele