Jr. Validation Engineer

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 escalate 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.

What we expect from you

• A completed BSc/HBO degree with at least 2 years of relevant experience in Biopharma and GMP;
• a technical or scientific background, with a process-oriented mindset within a production environment;
• willingness to combine project management and technical writing with hands-on activities, both independently and with support from Operations or the laboratory;
• approximately 60-80% of the tasks involve project management and writing, and 20-40% involve practical activities;
• experience with project management is a plus, but not required;
• capable of working and communicating at various levels within the organization, including department management, technical specialists, and operators;
• experience with sterilization validation, specifically validation of sterile filtration, is a major plus;
• strong professional command of both the Dutch and English languages.

What you can expect from us

TMC is an international high-tech consultancy company that brings expertise to its clients to support them in realizing their technological challenges. As such, TMC operates as an expert center at the service of its clients, helping them become more competitive in an increasingly global and rapidly changing technological world. At TMC, we believe that people are the driving force behind technological innovation. That’s why we aim to create the best possible conditions for tech talents to thrive. We offer a challenging and stimulating work environment where you can take charge of your own career. As an Employeneur, you are part of our TMC family. Beyond our outstanding technical expertise, fun and engagement are meaningful aspects of our culture.