CSV Analyst Entry Level

Job Title: CSV Analyst Entry Level

Type: Contract

Location: Remote

Experience:1-2 years

Job Summary

We are seeking an entry-level CSV Engineer to support validation of computerized systems used in pharmaceutical and life sciences environments. The role ensures systems are compliant, reliable, and meet regulatory requirements.

Key Responsibilities

• Assist in validation of computerized systems (e.g., LIMS, ERP, SCADA, MES)
• Prepare and execute validation documents: URS, FS, DS, IQ, OQ, PQ
• Ensure compliance with Good Manufacturing Practice (GMP) and 21 CFR Part 11
• Support risk assessments and validation planning
• Maintain proper documentation per Good Documentation Practices (GDP)
• Assist in audits and inspections
• Collaborate with QA, IT, and engineering teams
• Support change control, deviation, and CAPA processes
• Ensure data integrity and system compliance

Skills Required

Basic knowledge of Good Manufacturing Practice and Good Automated Manufacturing Practice, with understanding of validation lifecycle (URS, IQ, OQ, PQ)

Familiarity with computerized systems and data integrity principles

Strong documentation, analytical, and problem-solving skills

Good communication and basic IT knowledge

Preferred Skills

• Familiarity with systems like LIMS, SAP, MES, SCADA
• Knowledge of ISO 9001 and GxP environments
• Understanding of data integrity principles (ALCOA+)
• Internship or academic project in validation/QA/IT systems