Expert Science & Technology, Qualification Expert (f/m/d)
Job ID REQ-10044058
Mar 24, 2025
Austria
Summary
LOCATION: Schaftenau, Austria
ROLE TYPE: Hybrid Working, #LI-Hybrid
With over 200 programs in clinical development at Novartis at present and many of these including new molecular entities as well as additional indications and different formulations for marketed products we are creating medicines that could significantly advance treatment standards for patients worldwide.
As such we are seeking an Expert within Science& Technology to be a Qualification Expert as we continue to advance our programs.
About the Role
Key responsibilities:
* Qualification of analytical equipment, temperature-controlled storage cabinets and cold rooms in a Good Manufacturing Process (GMP) regulated environment
* Establish and drive qualification of complex state-of-the art analytical instruments (e.g. Mass Spectrometry) and related software
* Represent department in local and global initiatives related to equipment and software qualification
* Lead implementation of digital systems and represent the local and global organization in global teams
* Create and execute qualification, calibration and maintenance plans
* Provide technical trouble shooting during Performance Qualification (PQ) and validation
* Investigate deviations related to analytical equipment and temperature-controlled storage cabinets and cold rooms
REQUIREMENTS:
* Master’s degree in biotechnology, biochemical engineering, biology, chemistry, biochemistry or similar with at least 4 years strong relevant industry experience or PhD in relevant field or equivalent and 2+ years of work experience within the pharmaceutical industry in an GMP regulated environment
* Proficiency in English (and German is beneficial)
* Good knowledge analytical equipment qualification
* Proven experience within GMP environment
* Good theoretical and scientific knowledge in the area of expertise (like high performance liquid chromatography (HPLC), Capillary electrophoresis (CE) etc.)
* Knowledge in SAP and LIMS application
* Strong knowledge using digital system for planning and execution of equipment qualification
* A personality with a can-do mind-set and the ability to adopt to change with strong communication across organizational interfaces and presentation skills
* Ability to work and lead (a cross-functional team) in a matrix
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 € 60.212.18/year (on a full-time basis).
We also offer a potential market oriented excess payment in line with your experience and qualifications.
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive working environment and diverse teams, representative of the patients and communities we serve.
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?
AT33 (FCRS = AT033) Novartis Pharmaceutical Manufacturing GmbH
Functional Area Research & Development
Job Type Full time
Employment Type Regular
Shift Work No
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