Validation Specialist - Computer Systems

Job Description

Responsible for the computerized system validation and data integrity at the JHS-Spokane site. The job functions include periodic review and audit trail reviews. Drafting, reviewing, and executing equipment-specific test plans. Drafting and reviewing user requirement specifications, risk assessments, traceability matrix, and qualification protocols – including test plans and acceptance reports.

• Perform Periodic Reviews and Audit Trail Reviews of computerized systems.
• Write and review documents to support the qualification of a computerized system.
• Validation Plan
• User Requirements Specification
• Risk Assessment
• Traceability Matrix
• Qualification Protocol
• Qualification Test Plan
• Qualification Acceptance Report
• Validation Plan
• Acceptance Report
• Write and manage change control documents for computerized systems and assist with change controls for production computerized systems as necessary.
• Write and review CSV SOPs.
• Partner with other departments to ensure the site is compliant.
• Provide support for computerized systems during audits, deviations, and investigations.

Qualifications

• Minimum 5 years related experience with BS degree or 10 years of experience without BS degree.
• Experience with technical writing, building and manufacturing computer control processes/systems.
• QA operation systems and validation is required.
• GAMP 5 Certification strongly preferred.
• Experience with Data Integrity, Computer Software Validation, GMP records storage and SAP preferred.