Consultant

eMonkGlobal; Bengaluru; On-site; INR 2,000,000 - 3,000,000; Full time

Job summary

eMonkGlobal in Bengaluru is seeking an experienced CSV Subject Matter Expert to lead computer system validation projects across pharmaceutical, biotech, and medical device environments. You will develop and execute IQ/OQ/PQ validation protocols for GMP systems, ensure 21 CFR Part 11 compliance, train staff, and drive continuous improvements in validation processes.

The ideal candidate has 10+ years' experience, strong documentation and stakeholder management skills, and a track record of

Qualifications

• Proven experience in computer system validation within pharmaceutical, biotech, or medical device industries.
• Expertise in CSV approaches, SOPs, and validation life cycles.
• Strong knowledge of FDA regulations, GxP, and 21 CFR Part 11.

Responsibilities

• 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 validation processes and procedures.
• Develop and execute validation protocols (IQ/OQ/PQ) for computer systems and automated processes.
• Create validation plans, test scripts, and summary reports.
• Ensure all computer systems comply with FDA regulations, GxP guidelines, and 21 CFR Part 11.
• Provide training to staff on CSV processes and regulatory requirements.
• Stay updated on industry best practices and regulatory changes.

Skills

CSV

Stakeholder Management

Project Management

Project Governance

Education

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

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.

Required Skills

• Stakeholder Management
• Project Management
• Project Governance
• CSV