Validation Engineer
Take your validation expertise to the next level and tackle complex challenges in a high-tech, GMP-regulated environment.
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
As a Validation Engineer, you are responsible for validation activities across various technical projects within a highly regulated pharmaceutical environment.
You work both independently and as part of multidisciplinary teams on activities including:
- Performing Equipment Performance Qualifications (PQ), with a specific focus on cleaning and sterilization validation;
- Preparing Validation Master Plans (VMPs), validation protocols, and final reports;
- Conducting validation studies and analyzing and reporting the results;
- Maintaining SOPs and other relevant documentation to ensure they remain up to date;
- Identifying, analyzing, and resolving technical issues arising during validation studies;
- Working with filters and/or PUPSIT as part of validation processes;
- Managing and implementing changes within change management processes.
You collaborate with a variety of internal and external stakeholders while also being capable of independently managing and executing validation projects. You have a strong technical mindset, a high level of accuracy, and the ability to quickly become proficient in new IT systems.
What we expect from you
- A completed Bachelor’s degree (HBO or equivalent) in Chemical Engineering, Pharmaceutical Engineering, or a related field;
- A minimum of 5 years of relevant experience within the pharmaceutical industry;
- Experience with equipment validation and sterilization validation;
- Knowledge of sterile filtration, including complex oil/water mixtures;
- Knowledge of and experience with GMP and EU GMP Annex 1 requirements;
- Extensive experience in writing validation protocols, statements, and reports in accordance with pharmaceutical quality standards;
- Good command of both Dutch and English, written and spoken.
What you can expect from us
- A day-shift position, Monday to Friday;
- A high degree of independence and responsibility;
- The opportunity to work in a high-tech production environment;
- Extensive guidance and support from experienced colleagues and an Operational Coach;
- Plenty of opportunities for personal and professional development;
- The opportunity to work at the world’s largest Animal Health production site;
- A role in which your work directly contributes to improving animal health worldwide.
Great that you are interested in a job at TMC! Apply now in the way that suits you best and hopefully we can welcome you to one of our teams soon.