Jr. Validation Engineer

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

About this vacancy

Do you want to apply your expertise in GMP, validation, and sterile filtration within a complex pharmaceutical production environment? As a Validation Engineer, you will collaborate with a colleague to further professionalize filter validation within the production department. The goal is to validate existing sterile filtration steps and align the processes with Annex 1. In doing so, you will work closely with the Sub System Owner (SSO) Sterile Filtration, Quality, and various production departments and be involved in the entire process, from planning and preparation to execution and reporting.

What will you do?

• Draft, execute, and monitor a detailed project plan for filter validation;
• translate theoretical validation plans into a practical approach on the production floor;
• prepare, coordinate, execute, and report on validation tests;
• conduct both paper-based assessments and physical validation studies in production environments and the process development lab;
• ensure proper execution and documentation in accordance with GMP guidelines;
• identify and escape technical, compliance, and planning risks, and resolve them together with Production, Quality, and the SSO;
• actively identify opportunities to optimize the project both substantively and organizationally.