Engineer Qualification & Validation
- Employment type
- Full-time
- Location
- Rotkreuz
- Company
- Elan Personal AG, 6343 Rotkreuz
- First posted
Engineer Qualification & Validation
Roche Schweiz bridges the gap between pharmacy and diagnostics. Important research and development functions are located here. For our long-standing customer, Roche Diagnostics International AG in Rotkreuz, we are looking for an
Engineer Qualification & Validation
Background:
Do you not only want to manage documentation, but also contribute directly to the stability, compliance, and further development of our production with your know-how? Then this role is for you.
In our team, we are responsible for qualification and validation around our manufacturing equipment. This makes us an important partner for routine production and for improvements to existing plants and processes. For our site in Rotkreuz, we are looking for a personality who likes to take responsibility, works close to production, and pragmatically advances technical and compliance-related topics.
Tasks & Responsibilities:
You plan and coordinate qualifications from small equipment to complex production plants.
You create and moderate risk analyses and derive suitable measures from them.
You support process and method validations as well as requalifications and revalidations in the event of changes.
You actively work on improvement projects in our existing production.
You analyze disturbances, deviations, and technical questions in the production environment together with specialist departments.
You assess together with internal partners when there is a need for qualification or validation.
You coordinate independently with various stakeholders and keep topics reliably moving.
You support audits technically and represent your area of responsibility in a sovereign manner.
You ensure that regulatory requirements and internal quality standards are met.
Must Haves:
A completed degree in natural sciences, engineering sciences or a comparable field of study
2-3 years of experience in a regulated environment, for example in pharma, diagnostics, medical technology or a similar industry
Practical experience in qualifying equipment or plants
Knowledge of process and method validation is a plus
Experience with quality-related documentation and risk analyses
Technical understanding and interest in production-related topics
A structured, independent, and proactive way of working
Enjoyment of collaboration in interdisciplinary teams
Very good German language skills and good English language skills
What we offer:
An opportunity to contribute to one of the most important pharmaceutical companies in the world
Modern campus with plenty of green spaces and meeting zones
Central location with highway access and train station nearby
Varied activity profile
Home office possibility
Further training opportunities through temptraining
Collaboration in a dynamic and motivated team
Good compensation
You are welcome to send your complete application documents to Mr. Räfle.
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Posted 1 week ago