About this opportunity
Staftonic LLC lists this CSV Engineer opportunity in boston, Massachusetts. Review the employer’s description below for duties, qualifications and application requirements.
Job description
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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.
Seniority level
Seniority level
Mid-Senior level
Employment type
Employment type
Contract
Job function
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Worksite address
boston, MA, 02298, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.