CSV Engineer

Staftonic LLC; Boston (MA); On-site; USD 130,000 - 180,000; Part time

Job summary

A leading pharmaceutical company is seeking an experienced CSV Engineer in Boston, MA. The role requires 6–7 years in GxP environments and expertise in validating automation systems according to FDA and EMA guidelines. Responsibilities include executing validation protocols and ensuring data integrity. The ideal candidate holds a Bachelor’s in Engineering or related field. This contract position offers an annual salary range of $130,000 to $180,000.

Qualifications

• 6–7 years of experience in GxP pharma environments.
• Strong knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5.
• Hands-on experience in pharma CSV projects across multiple system types.

Responsibilities

• Author and execute URS, FS, Risk Assessments, IQ/OQ/PQ.
• Validate PLC, SCADA, DCS, LIMS, CDS, MES systems.
• 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.

Skills

GxP pharma environments

Validation of automation systems

Data integrity

Education

Bachelor’s in Engineering/CS or related field

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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