Validation Engineer — GMP Sterile Filtration

TMC; Eindhoven; On-site; EUR 52,000 - 75,000; Full time

Job summary

TMC in Eindhoven seeks a Validation Engineer to advance filter validation in a GMP environment. You will work with the SSO Sterile Filtration, Quality, and Production to validate existing sterile filtration steps and align processes with Annex 1, from planning to reporting.

Responsibilities include drafting, executing, and monitoring validation plans on the production floor and in the lab, performing paper-based and physical tests, ensuring GMP compliance, and identifying risks and optimization

Qualifications

• Experience with GMP guidelines and validation processes.
• Knowledge of sterile filtration in pharmaceutical production.
• Familiarity with Annex 1 requirements.

Responsibilities

• Draft, execute, and monitor a detailed project plan for filter validation.
• Translate theoretical validation plans into practical floor-level approaches.
• Prepare, coordinate, execute, and report validation tests.
• Conduct paper-based assessments and physical validation studies.
• Ensure proper execution and documentation per GMP guidelines.
• Identify and mitigate technical, compliance, and planning risks with Production, Quality, and SSO.
• Identify opportunities to optimize the project substantively and organizationally.

Skills

GMP

Validation

Sterile filtration

Project planning

Documentation

Risk assessment

Collaboration

Job description

TMC in Eindhoven seeks a Validation Engineer to advance filter validation in a GMP environment. You will work with the SSO Sterile Filtration, Quality, and Production to validate existing sterile filtration steps and align processes with Annex 1, from planning to reporting.

Responsibilities include drafting, executing, and monitoring validation plans on the production floor and in the lab, performing paper-based and physical tests, ensuring GMP compliance, and identifying risks and optimization