Location: Schaftenau, Tirol, Austria
We are seeking a Process Expert to join our Drug Substance Schaftenau team. In this role, you will play a key part in ensuring the safe, efficient, and compliant manufacture of high-quality products.
As a Subject Matter Expert (SME), you will support manufacturing operations through equipment qualification, cleanroom management, deviation handling, and the maintenance of GMP-compliant documentation. Working closely with cross-functional stakeholders, you will drive continuous improvement initiatives, support regulatory inspections, and contribute to operational excellence in a dynamic and innovative manufacturing environment.
Key Responsibilities
- Ensure manufacturing of high quality products on time, safe and efficient in the area of responsibility within the Process Support Unit.
- Coordinate equipment qualification and cleanroom-related activities.
- Handle deviations, implement and coordinate defined actions, and implement approved change requests.
- 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.
- Manage local administration of service providers for cleaning and gowning.
- Collaborate on and manage improvement projects in the production environment.
- Demonstrate a strong awareness of quality and a proactive, self-directed work approach.
Essential Requirements
- Bachelor's degree in a scientific or technical field such as Biotechnology, Biology, Chemistry, Pharmacy, Process Engineering, or a related discipline.
- Strong interest in technical processes, automation, engineering or manufacturing environments.
- High learning agility with the ability to quickly understand new concepts, systems, and technologies.
- Proactive mindset with a willingness to take initiative and seek continuous improvement opportunities.
- Strong problem-solving skills and a structured approach to technical challenges.
- Effective communication skills and the ability to collaborate in cross-functional and diverse teams.
- Fluent English communication skills, both written and spoken.
- Native-level German language skills.
Please submit your application documents, including your CV, in both German and English.
Benefits and Rewards
Expected Annual Base Salary Range for role: € 60.978,00 to € 89.300,00. In accordance with Austrian law, the minimum salary for this position is € 60.977,70 per year on a full time basis. Novartis also offers a potential market oriented excess payment in line with experience and qualifications.
Benefits may include a performance-based bonus, insurance plans, retirement plans, wellbeing resources, global recognition programs, flexible and hybrid working options where possible, and minimum 14 weeks paid parental leave.
Read more about the global rewards offering: Novartis Life Handbook
Accessibility and accommodation
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.
Job Details
- Division: Operations
- Business Unit: Production / Manufacturing
- Company / Legal Entity: AT33 Novartis Pharmaceutical Manufacturing GmbH
- Functional Area: Technical Operations
- Job Type: Full time
- Employment Type: Temporary (Fixed Term)
- Shift Work: No
Vollzeit
€ 4.355