Senior Expert Container Closure Integrity (m/f/d)
Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide.
The Technology and User Services (TUS) group in NX is driven to help users use tools effectively to improve productivity and foster innovation. We deliver the Technology and User Services (TUS) group in NX to help customers use tools effectively to improve productivity and foster innovation. Our organization is here providing the technology backbone and devices that enable users to work in an office, lab or mobile environment.
Senior Expert Container Closure Integrity (m/f/d)
As part of the Analytical Testing team within the Global Device & Packaging Development (GDPD) organization, you will join a collaborative environment at our scenic site in Schaftenau / Tyrol, Austria. Here, you will contribute to defining, coordinating, developing, and implementing innovative container closure integrity testing and control strategies together with a small CCI expert team, supporting one of the most diverse and advanced portfolios in the pharmaceutical industry.
Key responsibilities
- Lead the development, validation and transfer of deterministic state-of-the-art methods for container closure integrity testing (CCIT), with a special focus on methods for sterile products (e.g. biopharmaceuticals and small molecule drugs in prefilled syringes, cartridges, vials; some assembled into drug-delivery devices like autoinjectors or needle safety devices) but also for non-steriles (e.g. blisters for pills), for global implementation at Novartis Technical Development and Manufacturing sites
- Identify and evaluate respective test methods for primary packaging incoming control, drug product and final product in-process-control, release and stability testing; for example Helium leak detection, mass extraction, headspace analysis etc
- Drive collaboration with universities and expert companies, attend conferences to understand state-of-the-art CCIT at pharmaceutical industry, contribute to external networks
- Determine needed internal testing equipment and budget, convince stakeholders, organise equipment implementation and perform qualification
- Trouble-shoot method implementation challenges across locations and support root-cause investigations in case of CCI failure
- Strongly collaborate with laboratory colleagues, coach and work with students
- Author test method and equipment documents and testing reports
Essential Requirements:
- Bachelor’s, Master or PhD degree in engineering or natural sciences
- Strong knowledge of / working experience with container closure integrity testing and sterile drug products filling
- Interest and experience in working in state-of-the-art laboratory
- Strong skills in cross-functional coordination / project management, leading and influencing in global matrix organization, actively reaching out, able to understand and connect across functions
- Proficiency in English (oral and written), German skills are a plus
