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 opportunities 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.

- Strong 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)
🏢 eMonkGlobal
📍 Bangalore East