CSV Engineer (Pharma)

TL;DR

CSV Engineer (Pharma): Ensuring compliance of computerized systems with regulatory standards within a pharmaceutical environment with an accent on validation documentation and GxP regulations. Focus on preparing and approving validation records and supporting system integration activities to maintain regulatory compliance.

Location: Hybrid • Boxmeer (Netherlands)

Company

IT consultancy firm that helps startups, mid-sized and large corporations create and deliver innovative technologies across various industries.

What you will do

• Prepare, review, and approve validation documentation for computerized systems.
• Maintain accurate and compliant validation records in line with GxP regulations and internal protocols.
• Support validation and qualification activities to ensure system compliance.
• Train end users on proper system usage and regulatory compliance requirements.
• Collaborate with cross-functional teams to support system integration and improvements.

Requirements

• Bachelor's degree in IT, Business, or a related field.
• Experience working in a GxP-regulated environment.
• Understanding of computerized system validation (CSV) processes.
• Ability to work independently with moderate supervision.
• Excellent written communication skills in English.

Nice to have

• Knowledge of automation systems (ISA-95 level 2/3).
• Experience with SDLC (Systems Development Lifecycle).
• Exposure to manufacturing systems or pharma environments.