Validation Engineer Global External Manufacturing
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Roche Schweiz bridges the gap between pharmacy and diagnostics. Important research and development functions are located here. For our longstanding client, Roche Diagnostics International AG in Rotkreuz, we are looking for a
Validation Engineer Global External Manufacturing (GEM)
Background:
This is more than just a validation engineer position. You act as a reliable quality partner, auditor, supplier developer, technical expert, and diplomat. As an expert in validation, you will work together with our suppliers in qualification and validation projects. With your sound knowledge about quality regulations (e.g., IVDR / MDR, ISO 13485, 21 CFR 820), qualification and validation, and various production technologies, you will ensure that our high-quality products are manufactured in compliance with our standards and external regulations. Your main task is the supervision of qualification and validation activities with our suppliers. This encompasses process risk analyses, qualification and validation documentation, and the corresponding documented evidence.
The Perfect Candidate holds a Bachelor's Degree in an engineering or scientific/technical field, or equivalent experience, supplemented by at least 10 years of professional background in quality functions like Q&V or auditing within the Pharma or medical device sectors. The candidate possesses over 5 years of experience in external manufacturing and holds a deep understanding of relevant standards and automated production technologies, such as injection and blow molding. Additionally, the individual demonstrates a consistent commitment to personal and team development, paired with professional-level communication skills in both English and German.
Tasks & Responsibilities:
- Review and evaluate qualification and validation documents and process risk analyses provided by our suppliers
- Oversee the assessment of deviations related to qualification and validation activities, ensuring they meet our rigorous standards
- Meticulously document the outcomes of your evaluations in compliance with established quality standards
- Actively engage in the continuous improvement of processes, providing support in technical matters, and performing statistical data analyses
- Offer expert advice to suppliers on quality and compliance, ensuring adherence to all relevant quality standards and specifications
- Thrive in cross-departmental collaboration, working effectively within squads to achieve common goals
Must Haves:
- A Bachelor's Degree in engineering, scientific/technical field, or equivalent work experience, with at least 10 years of related experience (Q&V, Auditing, or Quality functions) in Pharma or the medical device industry
- At least 5 years of experience with external manufacturing business
- Profound understanding of applicable standards and norms, along with expertise in injection molding, blow molding, or other automated production technologies
- Demonstrate a continuous desire for learning and improvement both for yourself and your team members
- Excellent communication skills in English and German (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
- Certified Lean Six Sigma Green Belt / Black Belt
What We Offer You:
- A chance to contribute to one of the world's leading pharmaceutical companies
- Modern campus with plenty of green spaces and meeting areas
- Central location with highway access and nearby train station
- Varied job profile
- Home office options
- Opportunities for further training through temptraining
- Collaboration in a dynamic and motivated team
- Competitive salary
Please send your complete application documents to Mr. Severin Räfle.
Chemistry Pharma Pharmacy Diagnostics Zug Lucerne Full-time Research Laboratory
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