Ingénieur Validation Procédé - CDD 18 mois (H/F) " >Ingénieur Validation Procédé - CDD 18 mois (H/F)

Oct 29, 2021

Job Description

10 million doses is what the Huningue Biotechnology Center produces each year, which is a center of reference in the production of bio-drugs, clinical and commercial, by culturing mammalian cells.
"Quality and safety depend of course on our high-tech equipment, but they also and above all come from our teams, who bring innovation and improvement for the patient" explains Paula Rosa, Site Manager.
Come join a committed team of 700 people, in a motivating environment

Your responsibilities include, but are not limited to:
• Support site validation planning by writing and maintaining the validation plan for manufacturing and cleaning processes (packaging process is out of scope). Support
• Write and review manufacturing process validation protocols & reports. Support execution of validation activities at the shop floor. Review procedures, Master Batch Records and associated change controls (if applicable). Confirm revalidation need based on technical changes
• Define cleaning validation strategy and evaluate risks related to cleaning (do not author and Ensure that all Site validation activities are performed and are in line with the current Novartis requirements and cGMP, manage deviations associated with process validation and makes recommendations for deviation resolution as well as prevention of reoccurrence. Support Production Units by providing expertise in complex investigations

Diversity & Inclusion / EEO

Novartis s'engage à créer un environnement de travail exceptionnel et inclusif, ainsi qu'une équipe diversifiée, représentative des patients et des communautés que nous servons.

Minimum Requirements

What you’ll bring to the role:
• 1–2-year experience in manufacturing/ manufacturing science and technology/technical development/quality.
• Thorough understanding of manufacturing processes and related process equipment.
• Good working knowledge of quality systems and regulatory requirements across multiple health authorities.
• Experience in executing process validation.
• Experience in reviewing and writing technical reports.
• Proven project management experience in a cross-functional environment (e.g. multi-site, technical development, other functions).
• Fundamental understanding of standard pharmaceutical analytical testing.

Desirable requirements:
• BSc. in Chemistry, Pharmacy, Biology, Biochemistry and/or Biotechnology
• Fluent in English (CECR B2) and proficient in site local language

You’ll receive:
• A competitive salary
• An annual bonus
• A focus on your career development
• Access to our Quality of Life at work programme
• Flexible working
• Advanced social coverage for you and your loved ones
• 27 days of paid leave & 14 days of RTT per year
• Various employee recognition programs

Why consider Novartis?

799 million. That’s how many lives our products touched in 2019. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.
Imagine what you could do at Novartis!

Novartis has been certified as a "Top Employer" in France

Commitment to Diversity & Inclusion:

Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.

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:
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Ingénieur Validation Procédé - CDD 18 mois (H/F)

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