CSV Analyst Entry Level

Role overview

We are hiring an entry-level Computer System Validation (CSV) Analyst to help validate computerized systems used in pharmaceutical and life sciences settings. The role focuses on supporting compliance with GMP, GAMP 5, and 21 CFR Part 11 standards in a remote contract position.

Key responsibilities

• Assist with the validation of computerized platforms such as LIMS, ERP, MES, SCADA, and other GxP-related applications.
• Help create, review, and carry out validation deliverables and related documentation.
• Work on user requirements specifications (URS) and related validation artifacts.
• Support validation planning, risk assessment activities, and traceability exercises.
• Maintain alignment with Good Manufacturing Practices (GMP), GAMP 5, 21 CFR Part 11, and other applicable GxP expectations.
• Keep validation records organized and updated in line with Good Documentation Practices (GDP).
• Contribute to change control, deviation handling, CAPA actions, and periodic review tasks.
• Assist in internal audits, external audits, and regulatory inspection preparation and execution.
• Coordinate with QA, IT, Engineering, and business teams across the system validation lifecycle.
• Support data integrity efforts by following ALCOA+ principles and regulatory requirements.

Requirements

• Foundational understanding of the CSV lifecycle and standard validation documents.
• Working knowledge of GMP, GAMP 5, 21 CFR Part 11, and data integrity concepts.
• Good analytical thinking, documentation quality, and verbal/written communication skills.
• Exposure to LIMS, SAP, MES, or SCADA would be an advantage.
• Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, IT, Engineering, or a closely related discipline.

Additional information

This is a contract role based remotely. The stated experience range is 1–2 years.