CSV Validation Engineer — Pharma Systems Specialist

Pauwels Consulting; Geel; Sur place; EUR 60 000 - 85 000; Plein temps

Avantages offerts par ce poste

Challenging projects

Training opportunities

Networking events

Strong client network

Life Sciences focus

Clear career growth

Résumé du poste

Pauwels Consulting in Belgium is seeking a CSV Validation Specialist to join our Life Sciences team. You will execute validation activities across URS, IQ, OQ, PQ, and related processes, and maintain validation documentation to ensure cGMP compliance.

You will collaborate with project teams and QA to deliver compliant computerized systems, working independently and communicating effectively in English and Dutch within a fast-paced environment.

Qualifications

• 3+ years of experience in CSV (Computer System Validation) within a pharmaceutical or GMP environment.
• Expertise in validation documentation and execution of URS, IQ, OQ, and PQ protocols.
• Experience with software packages and computerized systems.
• Proactive and able to work independently.
• Strong communication skills; adaptable to new project environments.
• Fluent in English and Dutch.

Responsabilités

• Execute validation activities including URS, SIA, DQ, IQ, OQ, PQ, RV, and TM.
• Develop and maintain validation documentation such as protocols and reports for computerized systems.
• Ensure the validated status of systems remains compliant with cGMP and regulatory standards.
• Perform validation of software packages where industry standards require interpretation and specific application.
• Provide input into change assessments to determine potential impacts on validated status.
• Investigate and troubleshoot validation-related issues within the project environment.
• Collaborate with project teams and quality assurance stakeholders to meet deliverables.

Connaissances

CSV experience

Documentation

Independent worker

Communication

English & Dutch

Description du poste

Pauwels Consulting in Belgium is seeking a CSV Validation Specialist to join our Life Sciences team. You will execute validation activities across URS, IQ, OQ, PQ, and related processes, and maintain validation documentation to ensure cGMP compliance.

You will collaborate with project teams and QA to deliver compliant computerized systems, working independently and communicating effectively in English and Dutch within a fast-paced environment.