Engineer, Computer Software Assurance in Bangalore, भारत
Danaher
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
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