Mar 22, 2023

Job Description

2025 is the year when the new Aseptic production will be operational. 

We are building a brand new Aseptic Production Facility at our Ljubljana site with the newest technology, that will link the whole story from the production of biologics to the production of the final biologic medicines.

We are looking for a new team member in the MS&T team. This is an excellent opportunity for an experienced Validation expert who is looking to broaden their range of experience and who has a passion for working collaboratively to establish manufacturing processes that bring the latest technological and scientific product knowledge to life, with the ability to learn all aspects of manufacturing processes. The primary focus of this role is the responsibility of providing knowledge and facilitating/implementing the activities required to support the project plan and ensure the smooth commissioning of the facility and associated production equipment (filling line, aseptic techniques, equipment validations, smoke studies, etc.).

Your key responsibilities:
• Responsibility for providing knowledge and facilitating/implementing the activities necessary to support the project plan and ensure a smooth start-up of the facility (filling line, aseptic techniques, equipment validations, smoke studies, etc.).
• Collaboration, documentation and coordination in the introduction of new products, production of commissioning and qualification documents and supervision of implementation/rework, expansion and upgrade projects.
• Maintaining quality control of the production process of the selected product in production using computer tools.
• Participation and management of the implementation of optimization projects.
• Ensuring readiness for inspections.
• Conducting and supporting investigations into manufacturing defects.

Diversity & Inclusion / EEO

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

Minimum Requirements

What you will bring to the role:
• Bachelor's degree in pharmacy, pharmaceutical technology, chemistry, chemical technology, biochemistry, biotechnology, or other relevant scientific discipline (electrical, mechanical).
• Experience in a regulated environment related to commissioning, validation, and qualification in aseptic manufacturing.
• Independent and flexible working, good communication skills, openness to new solutions.
• Fluent in English.
• Knowledge of Microsoft Office.

You’ll receive
Competitive salary, Annual bonus, Flexible working schedule, tailored to your needs, possibility to work from home, Pension scheme, Employee Recognition Scheme, Expanded program for the promotion of health in the field of physical, mental and social well-being (Energized for Life), employment at Top SI Employer, Unlimited learning and development opportunities.

We offer permanent employment, with 6 months of probation period.

You are kindly invited to submit your application in English language, including CV by 5th of April 2023.

Why Novartis?
766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.

We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world's toughest medical challenges. Because the greatest risk in life, is the risk of never trying!

Imagine what you could do here at Novartis!

Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team's representative of the patients and communities we serve.

Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Novartis Technical Operations
Technical Operations
Full Time
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Validation expert (m/f/d)

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