Process Expert (m/f/d) - Schaftenau, Tirol

Job Description Summary

As a Process Expert, you will play a key role in ensuring the reliable, compliant, and efficient execution of aseptic filling processes within a highly regulated pharmaceutical environment.

 

Job Description

Main Responsibilities:

• Ensure business continuity for aseptic syringe‑filling operations by providing expert process support.
• Handle deviations end‑to‑end, ensuring timely investigation, documentation, and release of batches.
• Develop, own, and continuously improve processes, including writing and optimizing process documentation.
• Create and maintain life‑cycle documents to ensure compliance, accuracy, and inspection readiness.
• Represent the company as a Subject Matter Expert (SME) during Health Authority (HA) inspections.
• Collaborate with cross‑functional departments and manage stakeholders to align expectations and resolve issues efficiently.
• Participate in validation and qualification activities, supporting equipment, process, and system readiness.

Minimum Requirements:

• Completed technical or scientific degree (e.g., Process Engineering, Biotechnology, Technical Chemistry) or a comparable qualification.
• Strong English and German language skills (spoken and written).

Desirable Qualifications:

• Self‑driven and independent working style; ability to take ownership of topics from initiation to completion.
• Strong communication and collaboration skills, comfortable working with diverse teams.
• Hands‑on mindset — willing to enter production areas, interact with operators, and work directly with equipment; technical affinity required.
• Experience working in a GxP environment/GMP knowledge is an advantage.

What we offer:

Commitment to Diversity and Inclusion:

Novartis is committed to diversity, equity, and inclusion. We strive to build diverse teams that are representative of the patients and communities we serve. We are dedicated to creating an inclusive workplace that fosters bold innovation through collaboration and empowers our employees to reach their full potential.

Our hiring decisions are based on equal opportunity and the best qualifications, regardless of gender, religion, age, skin color, race, sexual orientation, nationality, or disability.

Support for Applicants with Disabilities:

In accordance with legal requirements, applicants with severe disabilities or equivalent status have the option to involve the local representative body for severely disabled employees (SBV) in the recruitment process. If this is your wish, please indicate this in advance by adding a note in your CV.

Join our Novartis Network:

If this position does not match your experience or career goals, but you would still like to stay connected with us and learn more about Novartis and our career opportunities, please join the Novartis Network here:

https://talentnetwork.novartis.com/network

 

Skills Desired

Data Analytics, digital skills, General Hse Knowledge  , gmp knowledge, process excellence, Resilience