Process Expert (m/f/d)

Biopharma Careers; Österreich; Hybrid; EUR 54.000 - 66.000; Vollzeit

Benefits dieser Stelle

Bonus program

Pension scheme

Childcare facilities

Learning opportunities

Zusammenfassung

Novartis in Schaftenau, Austria is seeking a Process Expert to ensure safe, efficient, GMP-compliant manufacture of high-quality drug substances. You will support manufacturing operations through equipment qualification, cleanroom management, deviation handling, and maintaining GMP documentation.

As SME, you will drive continuous improvement, support regulatory inspections, coordinate with cross-functional stakeholders, and lead improvement projects in production.

Qualifikationen

• Bachelor's degree or equivalent in a life sciences/engineering field.
• Strong team player with good communication in diverse teams.
• Proficiency in English; native German required.

Aufgaben

• Ensure manufacturing of high-quality products safely and efficiently in own area.
• Coordinate equipment qualification and cleanroom activities.
• Manage local admin for service providers (cleaning, gowning).
• Handle deviations, implement actions, and coordinate changes.
• Create and maintain lifecycle documents for compliance and inspections.
• Represent SME during Health Authority inspections.
• Collaborate with cross-functional stakeholders to resolve issues.
• Lead improvements in the production environment.

Kenntnisse

Team player

Communication

English proficiency

German native

Ausbildung

Bachelor's degree in Process Engineering, Biotechnology, Biology, Chemistry, Pharmacy

Tools

Automation affinity

GMP documentation

Jobbeschreibung

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.#LI-Hybrid

Location: Schaftenau, Tirol, Austria. Relocation Support: This role is based in Schaftenau Austria. Novartis is unable to offer relocation support: please only apply if accessible.

Major accountabilities

• Ensure manufacturing of high quality products on time, safe and efficient in the area of responsibility within theProcess Support Unit.
• Coordinate equipment qualification and cleanroom-related activities.
• Manage local administration of service providers for cleaning and gowning.
• 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.
• 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

• Minimum Bachelor’s degree or equivalent in Process Engineering, Biotechnology, Biology, Chemistry, Pharmacy, or a comparable field.
• Team player with good communication skills and confidence working in diverse teams.
• Proficiency in English, both spoken and written; native German speaker.

Desirable Qualifications

• Previous experience in the pharmaceutical industry.
• Good technical understanding and affinity for automation.
• Self-driven and independent working style, with the ability to take ownership of topics from initiation to completion.

Rewards

We 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 developmentopportunitiesas well as worldwide careerpossibilitieswithin the Novartis groupIn 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 € 59,781.96 /year (on afull timebasis). We also offer a potential market oriented excess payment in line with your experience and qualifications.The salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically.In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters. Further details will be provided during the application process.Pay equity is a fundamental principle of our employment policy and reflects our commitment to create a diverse, equitable and inclusive environment that treats all employees with dignity and respect, as outlined in our Code of Ethics.Note: Benefits and compensation may vary by country and are subject to local legal requirements, including provisions of collective bargaining agreements where applicable. A full overview of your compensation package, including any relevant collective bargaining agreement details applicable to your role based on your employment location and Novartis employer entity, will be communicated separately to you during the application process.Commitment to Diversity and Inclusion / EEO paragraph:Novartis is committed to building an outstanding, inclusive work environment and diverseteams’representative of the patients and communities we serve.