HHJ BAU GmbH seeks a Senior Validation Engineer for on-site freelance work in Zug, CH. The role focuses on evaluating supplier qualification documents, overseeing deviation assessments, and advising on quality compliance in the medical device or pharma sector.
This position serves as a technical expert who reviews and evaluates validation and qualification documentation provided by external manufacturing partners. The role also involves overseeing deviation assessments and providing specialized guidance on quality and regulatory compliance.
Responsibilities
- Assess and review qualification records, validation materials, and process risk analyses submitted by suppliers.
- Manage the evaluation of deviations connected to qualification and validation procedures.
- Record evaluation findings in accordance with relevant quality protocols.
- Drive ongoing process enhancements, including technical support and statistical analysis of data.
- Provide specialized guidance to suppliers regarding quality assurance and regulatory compliance.
- Collaborate within cross-functional squads to meet shared project objectives.
Requirements
- Hold a bachelor's degree in engineering, science, or a technical discipline.
- Possess professional experience in quality and validation, auditing, or quality assurance roles within the pharmaceutical or medical device sectors.
- Have prior exposure to external manufacturing operations.
- Demonstrate deep knowledge of relevant industry standards and expertise in injection molding, blow molding, or similar automated production methods.
- Communicate fluently in both English and German, at an excellent level for both written and spoken contexts.
Nice to have
- Understanding of computerized systems validation and controlled environment qualification per ISO 14644.
- Familiarity with product risk management frameworks, particularly ISO 14971.
- Certification as a Lean Six Sigma Green Belt or Black Belt.
What the company offers
- Opportunity to work in a highly innovative setting with an international team.
- Association with a highly recognized and established organization.
About the company
HHJ BAU GmbH connects engineering specialists with challenging projects across various industries. The firm maintains strong relationships with clients and supports candidates through every step of the recruitment journey, ensuring a smooth transition from initial contact to the start of the new role.
- Fosters an innovative and international work atmosphere.
- Provides dedicated support to professionals throughout the hiring process.
Quelle: öffentlich zugängliche Karriereseite des Arbeitgebers. Batchly ist nicht der Arbeitgeber und steht nicht notwendigerweise in einem Vertragsverhältnis mit dem Unternehmen.