Validation Engineer Global External Manufacturing
At Roche Schweiz, we bridge the gap between pharmacy and diagnostics, housing vital research and development functions. We are currently seeking a
Validation Engineer Global External Manufacturing (GEM)
Background:
This role transcends the typical validation engineer position. You will serve as a trusted quality partner, auditor, supplier developer, technical expert, and diplomat. With your extensive expertise in validation, you will collaborate with our suppliers on qualification and validation projects. Your deep understanding of quality regulations (e.g., IVDR/MDR, ISO 13485, 21 CFR 820), along with qualifications and validations, will ensure that our high-quality products are produced in compliance with both our standards and external regulations. Your primary responsibility will involve overseeing qualification and validation activities with our suppliers, encompassing process risk analyses, qualification and validation documentation, and the corresponding documented evidence.
The Perfect Candidate:
The ideal candidate will hold a Bachelor's Degree in an engineering or scientific/technical field, or possess equivalent experience, alongside a minimum of 10 years of professional background in quality functions such as Q&V or auditing within the pharmaceutical or medical device sectors. You will bring over 5 years of experience in external manufacturing and a comprehensive understanding of relevant standards and automated production technologies such as injection and blow molding. A consistent commitment to personal and team development, combined with professional-level communication skills in both English and German, is essential.
Tasks & Responsibilities:
- Review and evaluate qualification and validation documents as well as process risk analyses provided by our suppliers.
- Oversee the assessment of deviations related to qualification and validation activities, ensuring compliance with our rigorous standards.
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- Actively engage in the continuous improvement of processes, providing support on technical matters, and conducting statistical data analyses.
- Offer expert advice to suppliers on quality and compliance, ensuring adherence to all relevant quality standards and specifications.
- Thrive in collaborative efforts across departments, working effectively within teams to achieve common objectives.
Must Haves:
- A Bachelor's Degree in engineering, scientific/technical field, or equivalent work experience, with a minimum of 10 years of related experience in Q&V, auditing, or quality functions in the pharma or medical device industry.
- At least 5 years of experience in external manufacturing.
- A profound understanding of applicable standards and norms, along with expertise in injection molding, blow molding, or other automated production technologies.
- A passion for continuous learning and improvement for yourself and your team members.
- Excellent communication skills in English and German (both written and verbal).
Nice to Haves:
- Knowledge of computerized systems validation and controlled environment qualification (ISO 14644).
- Familiarity with product risk management according to ISO 14971.
- Certification as a Lean Six Sigma Green Belt / Black Belt.
What We Offer You:
- An opportunity to contribute to one of the world's leading pharmaceutical companies.
- A modern campus featuring green spaces and collaborative meeting areas.
- Central location with highway access and proximity to train stations.
- A diverse job profile.
- Home office options available.
- Opportunities for professional development through temptraining.
- Collaboration in a dynamic and motivated team.
- Competitive salary.
Apply online using the form below. Please note that only applications matching the job profile will be considered.
We look forward to your application!