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.

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.

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.

Required Skills

Stakeholder Management Project Management Project Governance CSV

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Consultant (Bengaluru)
🏢 eMonkGlobal
📍 Bengaluru