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 qualification records, supporting system integration, and training users on compliance requirements.

Location: Hybrid • Boxmeer, Netherlands

Company

hirify.global is an IT consultancy firm that helps startups and corporations deliver innovative software solutions across various industries, including Telecom, Pharma, and Automotive.

What you will do

• Prepare, review, and approve validation documentation.
• Maintain accurate and compliant validation records.
• Support validation and qualification activities for computerized systems.
• Ensure systems are used in line with GxP regulations and internal protocols.
• Train end users on proper system usage and 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.
• English: Excellent written communication skills required.

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.