Computer Systems Validation Engineer

• Bachelor's degree in engineering, computer science, information systems, life sciences, or a related discipline; equivalent relevant experience may be considered.
• Significant experience working in biotechnology, pharmaceutical, medical device, healthcare, or another regulated environment.
• Strong experience with Computer System Validation, Computer Software Assurance, quality systems, and data integrity principles.
• Demonstrated ability to lead validation activities across multiple computerized systems and projects, including setting validation strategy and providing direction to technical and business teams.
• Experience supporting regulatory inspections, audits, validation assessments, and quality-system documentation.
• Strong knowledge of GxP requirements, GAMP 5 and risk-based CSV/CSA principles, 21 CFR Part 11 and EU Annex 11 as applicable, ALCOA+ data integrity principles, and quality processes including change control, deviations, CAPA, and document control.
• Experience with functional risk assessments, requirements of traceability, supplier assessments, change control, deviations, CAPA, and periodic review.
• Experience authoring, reviewing, or executing IQ, OQ, PQ, UAT, or equivalent risk-based verification documentation.
• Familiarity with scripting, SQL, test automation, validation automation, electronic document management, quality management, or issue-tracking tools is advantageous.
• The physical and mental requirements of our roles include but are not limited to regular use of a computer, devices, or other office equipment, clear communication, and occasional movement. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.

Annualized Base Salary

$150,000—$178,000 USD