The Qualification Unit within Engineering and CSV at the Kaiseraugst site is seeking support for the qualification of embedded systems.
To ensure the success of the production site, we drive progress through scientific and technical expertise and forward-thinking service. We achieve this through continuous process improvement, an agile workforce, and a lot of passion. Due to our cross-functional role, you'll have numerous contacts across the entire manufacturing area.
General Information:
* Start date:
As soon as possible
* Latest possible start date:
February 1, 2026
* Planned duration:
2 years
* Extension:
Likely
* Workplace:
Kaiseraugst
* Workload:
100%
* Remote work:
Up to 20%
* Working hours:
Standard
Tasks & Responsibilities:
* Execute and document qualification processes for embedded systems/process automation systems in compliance with cGMP.
* Develop, implement, and execute test strategies, plans, and cases to verify system performance and compliance.
* Contribute to the creation of specifications (e.g., URS).
* Collaborate with IT, process engineering/automation, quality assurance, and production to ensure smooth integration and qualification of systems.
* Create and maintain qualification documentation (DQ, IQ, OQ, PQ) and supporting design documents such as data flow diagrams and audit trail review assessments.
* Handle qualification impact assessments within change and deviation process management.
* Work proactively and self-reflectively within expert teams.
Must-Haves:
* Degree in natural or engineering sciences or relevant professional experience.
* Minimum 3 years of professional experience with solid expertise in qualification processes and CSV.
* Hands-on experience with qualification and validation of various system types.
* Several years of experience in GMP environments with deep understanding of quality systems and lean GMP implementation.
* Strong strategic and conceptual skills, with excellent project and self-management abilities.
* Good documentation practices in GMP environments.
* Excellent English and German skills, both written and spoken.
Nice-to-Haves:
* Practical experience with common process control systems (e.g., Siemens Simatic).
* Solid knowledge of regulatory frameworks (ICP, GMP guidelines incl. Annex 11, Annex 22).
* Experience with fully electronic qualification (ValGenesis).
Personal Competencies:
* Highly independent and structured working style with a mindset for continuous self and process improvement.
* Strong initiative, flexibility, and quick comprehension.
* Solution-oriented approach, able to find practical paths even in complex situations.
* Strong communication skills for efficient teamwork.
* Team spirit, enthusiasm for cross-functional collaboration, and the ability to actively foster a positive work environment.