Engineer, Computer Software Assurance
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Job Description
Structured overview of role & requirementsAbout This Role
Lead and execute Computer System Validation (CSV) strategies and protocols ensuring compliance with FDA, ISO, and global GxP regulations.
Oversee validation activities for GxP-regulated computerized systems including ERP, QMS, MES, manufacturing software, and custom applications.
Ensure compliance with 21 CFR Part 11, 21 CFR Part 820, ISO 13485, focusing on software validation and electronic records
Minimum Requirements
5+ years experience in Computer System Validation within regulated medical device, pharmaceutical, or biotechnology environments.
Advanced knowledge and hands-on experience with 21 CFR Part 11, Part 820, ISO 13485, ISO 14971, GAMP5, FDA risk-based software validation guidance.
Experience planning, executing, and documenting validation of enterprise and manufacturing systems including IQ/OQ/PQ and validation reports.
Ability to travel as needed; remote work possible.
Ideal Candidate Profile
Demonstrated leadership in CSV within regulated environments supporting FDA and global regulatory compliance.
Strong technical writing skills with experience developing detailed validation documentation and controlled procedures.
Experience with data integrity, audit trails, system security, and familiarity with cloud/SaaS system validation and regulatory inspections is a plus.