Pharma CSV Validation Engineer (cGMP Systems)

AMARIS GROUP SA; Geel; Sur place; EUR 65 000 - 90 000; Plein temps

Avantages offerts par ce poste

Health insurance

Remote work

Meal vouchers

Time savings account

Referral bonus

Résumé du poste

Amaris Consulting is seeking a Validation Engineer – Computerized Systems in Belgium. You will plan, execute and maintain validation activities for cGMP‑critical software, ensuring systems stay validated and compliant with FDA/EU guidelines.

Role requires 3+ years in pharma GMP, strong knowledge of CSV, and ability to interact with QA, IT and engineering teams. English and Dutch fluency is expected.

Qualifications

• 3+ years of experience in the pharmaceutical sector and GMP environment.
• Solid knowledge of Computer Systems Validation and data integrity fundamentals.
• Experience validating software packages and computerized systems from planning to documentation.
• Strong troubleshooting skills for validation and system issues.

Responsabilités

• Plan, execute and maintain validation activities (URS, SIA, DQ, IQ, OQ, PQ, RV, TM) in cGMP.
• Prepare validation protocols and reports; support hands-on execution.
• Ensure validation docs are reviewed, approved and implemented.
• Interpret standards (FDA/EU, cGMP, cGLP) for validation projects.
• Assess impact of changes on validated status and determine needed tests.
• Investigate and resolve validation issues with corrective actions.

Connaissances

GxP

Computer Systems Validation

Pharma GMP

Software validation

Troubleshooting

Communication

English

Dutch

Description du poste

Amaris Consulting is seeking a Validation Engineer – Computerized Systems in Belgium. You will plan, execute and maintain validation activities for cGMP‑critical software, ensuring systems stay validated and compliant with FDA/EU guidelines.

Role requires 3+ years in pharma GMP, strong knowledge of CSV, and ability to interact with QA, IT and engineering teams. English and Dutch fluency is expected.