CSV Engineer

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Experienced CSV Engineer with 67 years in GxP pharma environments, skilled in validating automation, laboratory, and enterprise systems per FDA, EMA, and GAMP 5 guidelines, ensuring data integrity and compliance.

Key Responsibilities :

• Author and execute URS, FS, Risk Assessments, IQ / OQ / PQ, and summary reports.
• Validate PLC, SCADA, DCS, LIMS, CDS, MES, and related infrastructure.
• Ensure ALCOA+ data integrity and maintain the Validation Master Plan.
• Manage change control, CAPA, deviations, and revalidation.
• Support audits with complete CSV documentation.
• Collaborate with QA, IT, and Engineering to ensure compliant system lifecycle.

Qualifications :

Seniority level

Seniority level

Mid-Senior level

Employment type

Employment type

Contract

Job function

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