CSV Engineer (Boston)
$110kPart-time
Staftonic LLC
2 days ago Be among the first 25 applicants
Direct message the job poster from Staftonic LLC
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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