Bei Roche kannst du ganz du selbst sein und wirst für deine einzigartigen Qualitäten geschätzt. Unsere Kultur fördert persönlichen Ausdruck, offenen Dialog und echte Verbindungen. Hier wirst du für das, was du bist, wertgeschätzt, akzeptiert und respektiert. Dies schafft ein Umfeld, in dem du sowohl persönlich als auch beruflich wachsen kannst. Gemeinsam wollen wir Krankheiten vorbeugen, stoppen und heilen und sicherstellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und in Zukunft. Werde Teil von Roche, wo jede Stimme zählt.
Die Position
At the Kaiseraugst site, around 1,800 employees with an innovative spirit and the highest quality standards ensure the continuous supply of medicines to patients worldwide. As part of Pharma Technical Operations (PT), the site is a central pillar of sterile drug product manufacturing at Roche. The MSAT Sterile Team (Manufacturing Science and Technology) actively shapes the technological advancement, validation, and optimization of aseptic processes, combining scientific expertise with GMP compliance to ensure safe, efficient, and sustainable manufacturing processes for sterile drug products.
The Opportunity
As a Validation Expert - Drug Product Process Validation, you will be responsible for the design, execution, and GMP-compliant documentation of product-independent process validations within sterile drug product manufacturing. Working at the interface of Production, Engineering, Quality Assurance, and global network partners, you will make a decisive contribution to process safety and inspection readiness while shaping technical concepts, strategic network initiatives, and validation standards.
- Process Validation Execution: Design, plan, execute, and evaluate product-independent validation studies (e.g., Visual Inspection, Autoclaving, Sterilization-in-Place (SIP), Sterile Hold Time (SHT), and Crimping), including sample management, shipping, and GMP-compliant documentation.
- Technical Evaluations: Conduct technical assessments, root cause analyses, and prepare Quality Impact Assessments to ensure continuous process safety and quality.
- Project& Process Lifecycle: Manage or collaborate on local and cross-site validation projects, process improvements, and clinical Phase 3 manufacturing.
- Cross-Functional Collaboration: Partner closely with Kaiseraugst Manufacturing Units (Antibiotics& Sterile Filling), Engineering, Quality Assurance, and global network stakeholders.
- Global Network& Benchmarking: Discuss and benchmark validation concepts with Pharma Technical Development, and represent the department in huddles, steering, and planning meetings.
- Audit& Compliance Support: Ensure validation activities align with PQS and regulatory requirements, supporting health authority inspections, internal audits, and regulatory dossier preparation.
- Technical Impact& Visibility: Take on a high-visibility, interdisciplinary role with access to global know-how and digital tools, directly contributing to the safety and quality of life-saving medicines.
Who You Are
- Education& Professional Experience: Completed degree in pharmacy, natural sciences, engineering, or a comparable qualification, paired with several years of professional experience.
- Validation& GMP Expertise: Proven experience in planning, executing, and evaluating validation studies in a GMP environment, alongside a solid knowledge of sterile manufacturing processes.
- Communication& Collaboration: Excellent written and verbal communication skills in both German and English, with a strong ability to collaborate cross-functionally within a global network.
- Analytical& Proactive Mindset: High level of initiative, systematic thinking, and a solution-oriented working style, with a readiness to adapt to and actively shape new technologies and processes.
- Passion for Improvement: A strong willingness to learn, a passion for innovation, and an affinity for continuous improvement principles (Lean Thinking, LPS).
Ready to take the next step? We'd love to hear from you. Apply now to explore this exciting opportunity!
Wer wir sind
Eine gesündere Zukunft treibt uns zur Innovation an. Mehr als 100.000 Mitarbeiter weltweit arbeiten gemeinsam daran, wissenschaftliche Fortschritte zu erzielen und sicherzustellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und für zukünftige Generationen. Durch unser Engagement werden über 26 Millionen Menschen mit unseren Medikamenten behandelt und mehr als 30 Milliarden Tests mit unseren Diagnostik-Produkten durchgeführt. Wir ermutigen uns gegenseitig, neue Möglichkeiten zu erkunden, Kreativität zu fördern und hohe Ziele zu setzen, um lebensverändernde Gesundheitslösungen zu liefern.
Gemeinsam können wir eine gesündere Zukunft gestalten.
Roche ist ein Arbeitgeber, der die Chancengleichheit fördert.
