Process Expert (m/w/d)

Job Description Summary

Member of Process Support Unit and acting as Subject Matter Expert for Deviation handling and Change management.

The position supports the efficient and save manufacturing of high-quality drug substance on time, according to Novartis high standards of GMP/ HSE and environmental sustainability for the satisfaction of our customers.

 

Job Description

Key Responsibilities:

Your responsibilities include, but are not limited to:

• Ensure manufacturing of high quality products on time, safe and efficient in the area of responsibility.

• Coordinate and support process changes (PCC).

• Perform first line evaluation of product and process related issues, perform root-cause investigations (uncritical, major and critical deviations, OOS, OOE) and implement effective CAPAs.

• Support technology trainings and education programs for production operators and others.

• Preparation of production supporting documents, as well as for internal and regulatory inspections.

• Act as Subject Matter Expert for Audits.

Role Requirements:

• Completed studies in the field of Process Engineering, Biotechnology, Biology, Pharmaceutical Technology, Technical Chemistry, Pharmacy (or comparable studies), min. Bachelor's degree.

• GMP knowledge.

• Proficiency in English and German (spoken & written)

Desirable Requirements:

• First experience in the pharmaceutical industry, preferably manufacturing of large molecules or development.

• Experience in coordination, and coordination of internal and external stakeholders.

You’ll receive:

You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards

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 €58.199,96/year (on a full-time basis). The actual salary will be significantly 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.

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.

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.

 

Skills Desired

Change Control, Change Management, Continual Improvement Process, Efficiency, Good Documentation Practice, Knowledge Of Capa, Knowledge Of Gmp, Manufacturing, Manufacturing Process, Manufacturing Production, Process Control, Process Support, Production Line, Root Cause Analysis (RCA), Technology Transfer