CSV Project Manager

eMonkGlobal; Bengaluru; On-site; INR 2,500,000 - 4,500,000; Full time

Job summary

eMonkGlobal in Bengaluru seeks an experienced CSV Specialist to lead validation programs for computer systems in the pharma/biotech sector. You will develop IQ/OQ/PQ protocols, create validation plans, and ensure compliance with FDA/GxP standards, including 21 CFR Part 11.

The role requires 10+ years of domain experience and strong capability to train staff, drive improvements, and stay updated on regulatory changes.

Qualifications

• 10+ years of experience in computer system validation in pharma/biotech/medical devices.
• Experience developing/modifying CSV procedures and related documentation.
• Strong knowledge of FDA regulations, GxP, and 21 CFR Part 11.

Responsibilities

• Serve as SME in CSV processes and best practices.
• Develop and execute validation protocols (IQ/OQ/PQ) for computer systems and automated processes.
• Create validation plans, test scripts, and summary reports.
• Provide training on CSV processes and regulatory requirements.
• Identify opportunities for improving validation processes and procedures.

Skills

CSV processes

SME in validation

Regulatory guidance

Validation protocols

Training staff

Regulatory knowledge

Communication skills

Education

Bachelor’s degree in Biotechnology, Pharmacy, Computer Science, Engineering, Life Sciences, or related field

Advanced degrees or certifications in validation or quality/regulatory

Tools

Validation software/tools

Job description

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.
• 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.