Staftonic LLC
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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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Seniority level Mid-Senior level Employment type
Employment type Contract Job function
Referrals increase your chances of interviewing at Staftonic LLC by 2x Sign in to set job alerts for “Computer Systems Engineer” roles.
Boston, MA $160,000.00-$160,000.00 4 days ago Boston, MA $130,000.00-$180,000.00 6 months ago Boston, MA $90,000.00-$185,000.00 5 days ago Reading, MA $80,000.00-$100,000.00 2 weeks ago Boston, MA $150,000.00-$175,000.00 3 months ago Boston, MA $125,000.00-$178,000.00 1 month ago Boston, MA $80,000.00-$90,000.00 2 weeks ago Boston, MA $125,000.00-$178,000.00 4 months ago Boston, MA $100,000.00-$110,000.00 3 weeks ago Boston, MA $108,760.00-$173,800.00 4 days ago Software Engineer: Full-Stack Web Developer
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Boston, MA $190,000.00-$210,000.00 1 month ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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