Feb 12, 2024

About the Role

The Validation Expert performs and manages the qualification status of validated process equipment and processes, as well as modification activities to comply with cGMP requirements, on time and in the intended quality, so that site validation program conforms to overall regulatory expectations.

Your key responsibilities:

Your responsibilities include, but are not limited to:

• Prepare and verify process requalification protocols and reports and reports;
• Plan and perform periodic requalification activities related to manufacturing equipment and processes: i.e. sterilisation, cleaning, depyrogenation, VHP sanitisation processes, temperature mappings, integrity tests, aseptic process simulation (medium fill) processes;
• Ensure that all validation activities in the site are performed and in line with current Novartis and cGMP requirements, manage deviations related to process requalification, and make recommendations to remedy deviations and avoid their recurrence;
• Maintain all activities and projects in a state of inspection readiness under its own responsibility;
• Provide technical expertise for (and possibly facilitate) risk assessments using risk management tools. Collaborate cross-functionally to help ensure that process risks are analysed, adequately controlled and adequately documented.

Diversity & Inclusion / EEO

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Role Requirements

What you’ll bring to the role:

• Scientific or Engineering degree;
• Minimum 2 years of experience in a manufacturing / MS&T role within the pharmaceutical / biotech industry;
• In-depth knowledge of production processes and related process equipment;
• Fluent in English. Good knowledge of Dutch.

Work Location: Puurs (Belgium).

You’ll receive:

We offer you a challenging, international and interdisciplinary work environment. Investment in people is a priority for Novartis. We offer a range of possibilities for personal development and career opportunities within the group to motivated, qualified people. We offer you a competitive salary and benefit package. Novartis also supports a flexible work-life integration (working remotely, flexi-time schedules, ...). Your office will be based in Puurs. Locally, we offer benefits to ensure our associate's mental and physical well-being. There is a fitness available for our associates to use and we offer a bike-leasing program. We have a mental coach on site as well.

Why Novartis?

Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Technical Operations
Full Time
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Validation Expert

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