Senior Expert Container Closure Integrity (m/f/d)

Job Description Summary

#LI-Hybrid
Internal job title: Senior Expert - Science & Technology
Location: Schaftenau, Austria

Hundreds of drugs at Novartis require a special primary packaging (container) which maintains sterility and/or protects the drug from air/oxygen/humidity. Sensitive and reliable testing of container closure integrity (CCI) is therefore a crucial aspect for the development and manufacturing of high-quality drug products and drug-device combination products. 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.

 

Job Description

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

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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

Adjustments for Applicants with Disabilities: 

If because of a medical condition, physical disability or a neurodiverse condition you require an adjustment during the recruitment process, please reach out to disabilities.austria@novartis.com and let us know the nature of your request as well as your contact information. The support which we can provide will include advice on suitable positions as well as guidance at all stages of the application process. Austrian law provides candidates the opportunity to involve the local disability representative, Behindertenvertrauensperson (BVP), in the application process. If you would like to request this, please let us know in advance as a note on your CV.

What we offer:

In addition to a market-competitive base salary, we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development opportunities as well as worldwide career possibilities within the Novartis group.  In accordance with Austrian law, we are obliged to disclose the minimum salary as stated in the collective bargaining agreement. For this position the minimum salary is € 65,605.54/year (on a full-time basis). In most cases, the actual salary will be higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications and individual competencies. 

We are open for part-time and job-sharing models and support flexible and remote working where possible.

 

Skills Desired