Senior Computer System Validation (CSV) at Bayer

Department: Engineering & Technology

Setup: On-site
Location: Karnataka
Level: senior
Posted: Sep 9, 2026

Description

The Computer System Validation Engineer will lead validation activities for regulated R&D software tools, including Atlassian, IBM ELM, Jama, GitHub, and JFrog Artifactory. The role covers validation documentation, UAT, IQ, OQ, and PQ testing, GxP and 21 CFR Part 11 compliance, risk-based validation, change control, audit support, CAPA, and service management. It requires a relevant technical degree, more than five years of regulated software validation experience, knowledge of data integrity and CSV methodologies, and familiarity with the listed tools.

Required Skills

CSV
GxP
Data integrity
Risk-based validation
Change control
CAPA
IBM ELM
JIRA
JFrog

Additional Information

Minimum Education: Bachelor of Engineering, Bachelor of Technology, Bachelor of Science, or equivalent degree in Computer Science, Information Technology, Electronics, Biomedical Engineering, or a related technical discipline
Required Previous Experiences: More than 5 years of computer software validation experience in a regulated environment
Prior experience with CSV and CSA risk-based validation methodologies
Experience with GxP-regulated systems in pharmaceutical, medical device, or similarly regulated industries
Experience with internal or external audits and inspections
Experience supporting regulated R&D software environments
Previous Scrum Master experience using Jira
Preferred Qualifications: Administrator-level familiarity with IBM ELM, Atlassian, GitHub, and JFrog
Ability to collaborate effectively with global cross-functional teams