CSV Project Manager

Keka Inc.; Bengaluru; On-site; INR 3,500,000 - 7,000,000; Full time

Job summary

Keka Inc. in Bengaluru, Karnataka, seeks a senior CSV Validation Lead with 10+ years of experience in pharmaceutical, biotech, or medical device environments. You will own CSV governance, develop validation strategies, and guide cross-functional teams to ensure IQ/OQ/PQ-compliant systems and processes.

The role requires strong knowledge of FDA regulations, GxP, and 21 CFR Part 11, with proven ability to develop procedures, train staff, and drive continuous improvement in CSV practices.

Qualifications

• 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.

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 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.

Skills

Stakeholder Management

Project Management

Project Governance

CSV

Education

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

Advanced degrees or certifications in validation, quality assurance, or regulatory compliance

Job 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