Engineer, Computer Software Assurance

Overview

The Engineer, Computer Software Assurance ensures that computerized systems used in GxP processes comply with global regulatory requirements. The role provides strategic oversight of Computer System Validation activities across the organization and supports compliant system implementations.

What you'll do

• Lead, develop, and execute comprehensive Computer System Validation (CSV) strategies, plans, and protocols (IQ/OQ/PQ) in compliance with FDA and global regulatory requirements.
• Oversee validation activities for GxP-regulated computerized systems including ERP, QMS, MES, manufacturing equipment software, data integrity systems, and custom applications.
• Ensure systems meet 21 CFR Part 820, 21 CFR Part 11, and ISO 13485 requirements for software validation and electronic records/electronic signatures.
• Plan, execute, and document validation of enterprise and manufacturing systems.
• Develop validation documentation including URS, design specifications, traceability matrix, validation plans, IQ/OQ/PQ, summary reports, and controlled procedures.

What you'll need

• 5+ years of experience in Computer System Validation within a regulated medical device, pharmaceutical, or biotechnology environment.
• Advanced knowledge of and hands-on experience with 21 CFR Part 11, Part 820, ISO 13485, ISO 14971, GAMP5 guidelines, FDA guidance on risk-based software validation, and computer software assurance.
• Proven leadership in planning, executing, and documenting validation of enterprise and manufacturing systems.
• Strong understanding of data integrity requirements, audit trails, and system security principles.
• Excellent analytical, technical writing, and communication skills.

Nice to have

• Familiarity with EU MDR, Annex 11 (EU guidelines on computerized systems), and ISO 27001 (Information Security Management).
• Hands-on experience with validation of cloud-based or SaaS systems.
• Prior experience supporting FDA and Notified Body inspections as a CSV subject matter expert.
• Experience developing or enhancing CSV/QMS processes.

Details

• Location: Bengaluru, India.
• This position is eligible for a remote work arrangement in which you can work remotely from your home.
• Ability to travel as needed.