Validation Engineer (CSV)

Ensuring systems perform right the first time-every time, in full compliance.

R&D Partners is seeking a Validation Engineer (CSV) to join a leading biotechnology company in Belgium. This contract role focuses on the validation of software packages and computerized systems, ensuring compliance with cGMP standards.

Please note that to be considered for this role you must have the right to work in this location.

Responsibilities:

• Develop, implement, and execute URS, SIA, DQ, IQ, OQ, PQ, RV, and TM activities.
• Conduct validation studies for cGMP-critical computerized systems to meet user and regulatory requirements.
• Generate validation documentation, including protocols and reports, and assist with protocol execution.
• Ensure validated status of computerized systems aligns with cGMP standards.
• Manage projects in compliance with cGMP regulatory standards.
• Stay updated on emerging validation regulations and testing practices.
• Provide technical assistance on US FDA and EU validation requirements.
• Assess changes for impact on validated status and documentation.
• Investigate and troubleshoot validation issues.

Key Skills and Requirements:

• Strong communication skills and ability to work independently.
• Competent knowledge of Computer Systems Validation (CSV).
• Full understanding of quality and compliance regulations.
• Minimum 3 years of experience in the pharmaceutical sector and GMP environment.
• Proficiency in English and Dutch.
• Experience with DCS systems, particularly Emerson DeltaV, is an advantage.

For more information, please contact Grant Van Schalkwyk.

If you are interested in applying to this exciting opportunity, then please click ‘Apply’ or to speak to one of our specialists visit the ‘Contact Us’ page.

R&D Partners is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. R&D Partners is acting as an Employment Agency in relation to this vacancy.

By submitting this application, you confirm that you’ve read and understood our privacy policy, which informs you how we process and safeguard your data – https://www.r-dpartners.com/privacy-policy/