CSV Validation Engineer | Pharmaceuticals | Belgium

About the Role:

We are seeking a skilled CSV (Computer Systems Validation) Validation Engineer to join an exciting project for a leading pharmaceutical company. The role involves working on the validation of pharmaceutical machinery used in tablet production. The initial phase of this project will take place in Belgium, with further installations planned overseas. The successful candidate will ensure all systems comply with regulatory requirements, ensuring that the systems are fit for use in a highly regulated pharmaceutical environment.

Role & Work Structure:

• Location: Antwerp, Belgium (continental travel expected)
• CSV Validation Focus: The candidate will be responsible for the validation of computer systems that control and monitor equipment used in tablet production. This includes ensuring that the systems meet the highest standards of GxP (Good Automated Manufacturing Practice), 21 CFR Part 11, and EU Annex 11.
• Hands-on Work: The role requires working with physical equipment and software systems to ensure they are compliant with regulatory standards before being shipped for use in countries such as China and the US.
• Compliance: You will validate software and hardware systems, develop validation protocols, perform risk assessments, and generate validation reports.

Key Responsibilities:

• Perform CSV validation of computer systems used in pharmaceutical production, including software, hardware, and automated systems.
• Develop and execute validation protocols (IQ, OQ, PQ) and ensure all documentation meets GxP and regulatory compliance standards.
• Collaborate with cross-functional teams to ensure that systems are designed, implemented, and maintained in compliance with 21 CFR Part 11 and EU Annex 11.
• Review and approve CSV validation documentation, including risk assessments, validation plans, and test results.
• Ensure data integrity and system security throughout the validation process.
• Support change control, deviations, and CAPA (Corrective and Preventive Actions) processes.

Candidate Profile & Compensation:

• Experience: 3+ years of experience in CSV validation within the pharmaceutical or biotechnology industries.
• Key Skills: Proficient in computer systems validation (CSV) processes, including design, execution, and documentation of validation protocols such as IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification).
• Experience with validation of software, hardware, and automation systems used in pharmaceutical production processes.
• Knowledge of GxP regulations, 21 CFR Part 11, EU Annex 11, and industry standards for pharmaceutical systems.
• Strong understanding of data integrity and regulatory compliance within pharmaceutical manufacturing.
• Language Requirements: English

If you have experience in CSV validation and are looking for a role where you can apply your skills in a challenging, global pharmaceutical project, we encourage you to apply!