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Experienced CSV Engineer with 6–7 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:
- Bachelor’s in Engineering/CS or related field.
- Strong knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5.
- Hands-on experience in pharma CSV projects across multiple system types.
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Mid-Senior level
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