Validation Engineer Global External Manufacturing

Validation Engineer Global External Manufacturing

Roche Schweiz plays a pivotal role at the intersection of pharmacy and diagnostics, hosting crucial research and development functions. We are seeking an adept professional to serve as a reliable quality partner, auditor, supplier developer, technical expert, and diplomat in the validation engineering domain.

Background

This role transcends traditional validation responsibilities, focusing on collaboration with suppliers on qualification and validation projects. With a comprehensive understanding of quality regulations such as IVDR / MDR, ISO 13485, and 21 CFR 820, you will ensure that our high-quality products are produced in accordance with both internal and external standards.

Your primary responsibility will involve supervising qualification and validation activities, which includes conducting process risk analyses, managing qualification and validation documentation, and providing the relevant documented evidence.

Candidate Profile

The ideal candidate will possess the following qualifications:

• A Bachelor's Degree in an engineering or scientific/technical field, or equivalent experience, complemented by at least 10 years in quality functions such as Quality & Validation (Q&V) or auditing within the Pharma or medical device sectors.
• A minimum of 5 years of experience working in external manufacturing.
• A deep understanding of relevant standards and automated production technologies, including injection and blow molding.
• A commitment to continuous learning and development, with strong communication skills in both English and German.

Key Responsibilities

• Review and evaluate qualification and validation documents and process risk analyses submitted by suppliers.
• Oversee the assessment of deviations related to qualification and validation activities, ensuring alignment with rigorous quality standards.
• Document outcomes of evaluations meticulously to comply with established quality benchmarks.
• Engage in continuous process improvement, provide technical support, and perform statistical data analyses.
• Advise suppliers on quality and compliance to maintain adherence to all relevant specifications.
• Collaborate effectively across departments to achieve shared objectives.

Essential Qualifications

• A Bachelor's Degree in an engineering, scientific/technical field, or equivalent work experience, paired with a minimum of 10 years of experience in relevant fields (Q&V, Auditing, or Quality functions) in Pharma or the medical device industry.
• At least 5 years of experience in external manufacturing.
• A profound understanding of applicable standards and norms, alongside expertise in injection molding, blow molding, or other automated technologies.
• A passion for personal and team development.
• Proficient communication skills in English and German (both written and verbal).

Desirable Qualifications

• Knowledge of computerized systems validation and controlled environment qualification (ISO 14644).
• Familiarity with product risk management in accordance with ISO 14971.
• Certification as a Lean Six Sigma Green Belt or Black Belt.

Benefits

Joining our team provides an opportunity to contribute to one of the world's leading pharmaceutical companies, accompanied by a modern campus, ample green spaces, and meeting areas. Our central location offers convenient highway access and proximity to a train station. Enjoy a varied job profile with options for home office arrangements, further training through temptraining, collaboration within a dynamic and motivated team, and a competitive salary.