Impel Talent is leading a confidential search for a Computer System Validation (CSV) Specialist to join a prestigious global player in the pharmaceutical sector. This family-owned company is a leader in regulated manufacturing, renowned for its investment in compliance, digital innovation, and cutting-edge technology.
As a CSV Engineer, you will:
- Author and execute validation documentation, including plans, protocols (IQ/OQ/PQ), and final reports in accordance with regulatory standards.
- Validate computer systems for data integrity, security, audit trails, and access control functionality.
- Evaluate software risk and vendor documentation to ensure compliance with GxP and data integrity requirements.
- Work closely with QA, IT/OT, Engineering, and Automation teams to ensure validated state of computerized systems.
- Support change management, upgrades, and lifecycle activities with appropriate validation strategies and documentation.
- Contribute to the development and improvement of internal policies, SOPs, and validation templates.
About You:
You are a detail-oriented CSV professional with a deep understanding of GxP compliance and regulatory expectations for computerized systems. You thrive in cross-functional environments and bring a pragmatic approach to risk-based validation.
Key Requirements:
- Bachelor’s degree in Engineering, Computer Science, or a related technical field.
- 5+ years of CSV experience in GMP-regulated industries.
- Strong knowledge of GAMP 5, 21 CFR Part 11, and EU Annex 11.
- Hands-on experience with validation of systems such as SCADA, MES, ERP, or DCS (e.g., Siemens WinCC, Delta V).
- Excellent written and verbal communication skills in English.
This role offers a chance to shape the digital compliance landscape of a high-performing global manufacturer. If you’re ready to play a key role in validation excellence, we’d love to connect with you.
To Apply: Reach out to Impel Talent in full confidence. Only shortlisted candidates will be contacted.
Email me directly at: Uri.lourenco@impeltalent.com or alternatively connect with me on LinkedIn at: https://www.linkedin.com/in/uri-l-8a2187242/
