Roche seeks a Validation Expert for a 2-year temporary role in Kaiseraugst, focusing on GMP-compliant process validation for sterile drug products within the Pharma Technical Operations team.
This position supports the MSAT Sterile Team at the Kaiseraugst site by managing the full lifecycle of product-independent process validations. The expert ensures that sterile manufacturing processes meet strict quality and safety standards through rigorous design, execution, and documentation.
Responsibilities
- Plan and carry out validation studies such as visual inspection, autoclaving, sterilization-in-place, sterile hold time, and crimping, including all related sample handling and GMP documentation.
- Perform technical assessments, root cause analyses, and quality impact evaluations to maintain process integrity.
- Lead or assist in local and cross-site validation initiatives, process enhancements, and Phase 3 clinical manufacturing efforts.
- Collaborate with manufacturing units, engineering, quality assurance, and global stakeholders to align validation activities.
- Benchmark validation strategies with Pharma Technical Development and participate in planning and steering meetings.
- Ensure compliance with the Pharmaceutical Quality System (PQS) and regulatory standards, supporting audits and health authority inspections.
Requirements
- A completed degree in pharmacy, natural sciences, engineering, or a similar field.
- Several years of professional experience in a relevant industry.
- Demonstrated ability to plan, execute, and evaluate validation studies within a GMP environment.
- Strong understanding of sterile manufacturing processes.
- Fluency in both German and English, with excellent written and verbal communication skills.
Nice to have
- Familiarity with continuous improvement methodologies such as Lean Thinking or the Lean Production System (LPS).
What the company offers
- Opportunities to leverage global expertise and access to advanced digital tools.
About the company
Roche is a global healthcare company with over 100,000 employees dedicated to advancing science. The organization’s mission is to prevent, stop, and cure diseases while ensuring equitable access to healthcare for current and future generations. The workplace culture fosters open dialogue, personal expression, and mutual respect, valuing genuine connections among its staff.
- Encourages personal expression and open dialogue.
- Values genuine connections and mutual respect among employees.
- Dedicated to advancing science to prevent, stop, and cure diseases.
- Committed to ensuring global access to healthcare.
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