Engineer, Computer Software Assurance in Bangalore, भारत

Masimo, a Danaher operating company, seeks an engineer to lead computer system validation activities ensuring GxP-regulated systems comply with FDA, ISO, and global regulatory standards. The role involves developing CSV strategies, overseeing validation of enterprise and manufacturing systems, and maintaining compliance documentation.

Responsibilities

• Lead development and execution of comprehensive Computer System Validation strategies, plans, and protocols
• Oversee validation activities for GxP-regulated systems including ERP, QMS, MES, and custom applications
• Ensure systems meet 21 CFR Part 820, Part 11, and ISO 13485 requirements for software validation
• Provide strategic oversight of CSV activities across the organization to enable compliant system implementations

Requirements

• 5+ years of Computer System Validation experience in regulated medical device, pharmaceutical, or biotechnology environments
• Advanced knowledge of 21 CFR Part 11, Part 820, ISO 13485, ISO 14971, and GAMP5 guidelines
• Proven leadership in planning, executing, and documenting validation of enterprise and manufacturing systems
• Strong understanding of data integrity, audit trails, and system security principles
• Experience developing validation documentation including URS, design specs, traceability matrix, IQ/OQ/PQ protocols
• Excellent analytical, technical writing, and communication skills