Jr. Validation Engineer

StudentJob; Eindhoven; On-site; EUR 50,000 - 70,000; Full time

Job summary

TMC is an international high-tech consultancy. They seek a Validation Engineer to validate sterile filtration steps, align processes with Annex 1, and collaborate with the SSO Sterile Filtration, Quality, and production teams.

You will manage projects, write validation reports, and perform on-floor validation in GMP environments, contributing to the overall quality and efficiency of pharmaceutical production.

Qualifications

• Completed BSc/HBO with at least 2 years of relevant Biopharma GMP experience.
• Strong technical and scientific background with a process-oriented mindset.
• Willingness to combine project management and technical writing with hands-on activities.

Responsibilities

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

Skills

Project management

Technical writing

Sterilization validation

GMP knowledge

Biopharma

English proficiency

Education

BSc/HBO degree in Biopharma or related field

Job description

About The Member Company

We are a global high-tech consultancy company with a team of entrepreneurial engineers, scientists, and digital experts from around the world. Together we form a fast-growing and proud community. We offer consultancy services to high-profile clients globally in diverse service areas, such as:

• Technology & Engineering
• Energy & Renewables
• Life sciences & Pharma
• Digital & IT

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 elevate 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.

Salarisomschrijving

In overeenstemming

Vaardigheden

• Je beheerst Engels

Opleiding

HBO