- Fulltime
- NL - Oss
Validation Engineer
As a Validation Engineer, you play a key role in ensuring compliance within the life sciences, joining the team in Oss, the Netherlands. You support organizations in validating and optimizing processes, systems and facilities that comply with strict regulations such as GMP, ISO, FDA and EMA. Whether it is the start-up of a project or a periodic re-qualification, you deliver smart, well thought-out solutions that combine sustainable compliance and operational efficiency.
Do you get excited about quality-oriented challenges in a regulated environment? Then we would like to welcome you as a Validation Engineer at Normec Advipro!
This is Normec Advipro
Normec Advipro ensures that organizations in the life sciences meet all relevant regulations and remain sustainably compliant. With in-depth expertise in GMP, ISO standards, FDA, EMA and other regulators, we implement efficient and future-proof solutions. From project initiation to re-qualification, we support our customers at every stage for optimal performance and risk management.
Your challenge at Normec Advipro
As Validation Engineer, you have a helicopter view and you are the one who keeps an overview of the validation status of pharmaceutical production systems. In this you take responsibility and you are the process owner of validation & qualification.
As a technical expert, you provide the necessary support in the area of validation of GMP-critical (production) machines. In addition, you are responsible for providing advice on cGMP aspects and you provide support during internal and external inspections. Naturally, you are also part of the Engineering team.
Some of your other tasks include risk analyses, validation protocols and reports. These therefore hold no secrets for you.
Are you....
- A person with a helicopter view, structure and the one who always keeps the overview? Do you have:
- You are in possession of a higher technical education;
- At least 3 years of experience in engineering and in a GMP environment;
- Quality and technical aspects of pharmaceutical production installations, cleanrooms and utilities are your passion;
- Experience with various activities concerning validation and qualification. This holds no secrets for you;
- Managing documents is your thing; You draft them, modify them after review and take care of the approvals;
- Communicative and organizational skills, you speak and write Dutch and English fluently;
- Finally, if you have a sense of humor, enthusiasm, commitment and passion, you will have an advantage over the rest!
What can you expect from Normec Advipro?
- A competitive salary and good working conditions;
- A dynamic company in full growth with a no-nonsense culture and where there is plenty of room for own initiative;
- An enthusiastic and cozy team full of team activities: Sinterklaas and staff party, team building, ...
- At Normec Advipro we work together, keep each other sharp and inspire each other: think tanks, focus groups, brainstorms, ... .
- We offer you challenges, training, career opportunities and the chance to shape your job yourself.
- Extensive range of fringe benefits. Count on financial growth based on performance and bonuses such as profit-sharing bonus and referral program.