Engineer, Computer Software Assurance

Minimum Qualifications

• 5+ years of experience in Computer System Validation within a regulated medical device, pharmaceutical, or biotechnology environment preferred.
• 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.
• Experience developing validation documentation including URS, design specifications, traceability matrix, validation plans, IQ/OQ/PQ, summary reports, and controlled procedures .
• Excellent analytical, technical writing, and communication skills.

Preferred Qualifications

• 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.

Education

Location