CSV Engineer

Intellectt INC; New Jersey; On-site; USD 59,000 - 66,000; Full time

Job summary

Intellectt INC. seeks a Computer System Validation (CSV) Engineer to support validation activities for computerized systems in a GMP-regulated pharmaceutical setting.

The candidate should have hands-on CSV lifecycle documentation experience, including IQ/OQ/PQ, Traceability Matrix, and Validation Summary Reports, with strong GAMP 5 and 21 CFR Part 11 knowledge. The role requires collaborating with QA, IT, Engineering, and Manufacturing to ensure systems remain validated and compliant across

Qualifications

• Bachelor's degree in Engineering, Computer Science, Life Sciences, or related field.
• 4+ years of CSV experience in the Pharmaceutical or Biotech industry.
• Strong knowledge of GAMP 5, 21 CFR Part 11, GxP, and Data Integrity.
• Hands-on CSV lifecycle documentation and IQ/OQ/PQ execution.

Responsibilities

• Develop and execute CSV documentation, including URS, Risk Assessments, IQ/OQ/PQ, Traceability Matrix, and Validation Summary Reports.
• Perform validation activities for GxP computerized systems and ensure systems remain in a validated state.
• Ensure compliance with GAMP 5, 21 CFR Part 11, EU Annex 11, GMP, and Data Integrity requirements.
• Support Change Controls, Deviations, CAPA, periodic reviews, and audit activities.
• Collaborate with QA, IT, Engineering, Manufacturing, and cross-functional teams.

Skills

CSV lifecycle documentation

GAMP 5

21 CFR Part 11

GxP

Data Integrity

Education

Bachelor's degree in Engineering, Computer Science, Life Sciences, or related field

Tools

LIMS

MES

SCADA

ERP

QMS

Job description

Title: Computer System Validation (CSV) Engineer
Location: New Jersey
Duration: 6+ Months
Industry: Pharmaceutical
Employment Type: Contract
Payrate: $43 - $48/hr on W2

Job Description

We are seeking an experienced Computer System Validation (CSV) Engineer to support validation activities for computerized systems within a GMP-regulated pharmaceutical environment. The ideal candidate will have strong hands-on experience with CSV lifecycle documentation, GAMP 5, 21 CFR Part 11, and GxP compliance.

Responsibilities

• Develop and execute CSV documentation, including URS, Risk Assessments, IQ/OQ/PQ, Traceability Matrix, and Validation Summary Reports.
• Perform validation activities for GxP computerized systems and ensure systems remain in a validated state.
• Ensure compliance with GAMP 5, 21 CFR Part 11, EU Annex 11, GMP, and Data Integrity requirements.
• Support Change Controls, Deviations, CAPA, periodic reviews, and audit activities.
• Collaborate with QA, IT, Engineering, Manufacturing, and cross-functional teams.

Requirements

• Bachelor's degree in Engineering, Computer Science, Life Sciences, or related field.
• 4+ years of CSV experience in the Pharmaceutical or Biotech industry.
• Strong knowledge of GAMP 5, 21 CFR Part 11, GxP, and Data Integrity.
• Hands-on experience with CSV lifecycle documentation and IQ/OQ/PQ execution.
• Experience with systems such as LIMS, MES, SCADA, ERP, or QMS is preferred.