Computer Systems Validation Analyst
1 day ago
Computer Systems Validation Specialist
Job Summary:The Computer Systems Validation Specialist will lead and execute validation activities for GxP electronic systems, with a focus on Systems MES (Emerson) integrations and recipe functions. This role is an individual contributor with occasional oversight of contract resources on a project basis.
Key Responsibilities:- Lead site-specific CSV activities for computer system integration projects, coordinating with the global/site specific system technology and validation teams.
- Develop and manage validation deliverables for site-level electronic systems and applications that integrate with enterprise systems.
- Ensure that routine tasks supporting validation of electronic systems and applications supporting clinical and commercial drug product manufacturing are documented in accordance with the relevant company procedures and health authority regulations.
- Coordinate system validation assessments, periodic reviews, and audit activities.
- Master's Degree with 2+ years of direct experience in Validation in a pharmaceutical, biotechnology, or related industry, preferably in FDA-regulated environments, OR; Bachelor's Degree with 4+ years of direct experience in Validation in a pharmaceutical, biotechnology, or related industry, preferably in FDA-regulated environments.
- Experience in a biotechnology or pharmaceutical cGMP manufacturing environment preferred.
- Experience with development of CSV documentation (Validation Plans, Requirements, Specifications, Assessments, Test Scripts [IQ / OQ / PQ], Reports, Trace Matrices, SOPs, etc.).
- 3-5+ years' experience in performing periodic review of computerized systems.
- Experience with Valgenesis/Veeva Vault CR/PR/CAPA systems.
- Strong critical thinking and problem-solving skills.
- Strong interpersonal skills to work with teams in different functions and organizations.
- GXP Equipment Validation.
This role is an onsite position in Bothell, WA. Local candidates are preferred.
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