Qualification und Validation Expert (m/f/d)

We are proud to be a first-tier supplier to Roche. For our valued partner, F. Hoffmann-La Roche Ltd. based in Kaiseraugst, we are currently seeking a motivated Qualification & Validation Expert for a temporary position of one year with the possibility of extension.

The Qualification Unit within Engineering and SHE at the Kaiseraugst site is looking for support in the qualification of Embedded Systems.These systems are production assets integrated with embedded process automation technologies such as SCADA/HMI. To maintain the high standards of our successful production site in Kaiseraugst, we drive innovation through scientific and technical excellence, paired with proactive service. Our success is built on continuous process improvement, an agile workforce, and a deep passion for what we do.

Key Tasks & Responsibilities:

• Plan and execute qualification and validation activities (DQ, IQ, OQ, PQ) for Embedded Systems
• Ensure compliance with cGMP through proper documentation and execution of qualification processes
• Develop and perform test strategies, plans, and cases for system performance and compliance
• Collaborate with IT, automation, QA, and production to integrate and qualify systems
• Create technical specifications such as URS
• Support deviation, change, and CAPA management processes

Key Must-Haves:

• Technical degree and practical GMP experience
• 3-5 years of hands-on qualification/validation experience, ideally in pharma
• Solid understanding of CSV and process automation
• Experience with Siemens COMOS, ValGenesis (EVAL), and VIVA preferred
• Fluency in German (spoken/written) and English (written/reading)
• Independent, structured work style with strong initiative and team spirit

Benefits:

• Enjoy exclusive discounts all year round at renowned retailers and over 200 top brands
• Benefit from fleet discounts when purchasing a new car or receive consistent fuel discounts with our fuel card
• Be part of one of the most prestigious pharmaceutical companies and actively shape the future of healthcare
• Work on a state-of-the-art campus with green spaces, social areas, and an inspiring atmosphere
• Take advantage of attractive fitness and swimming pool offers or use the gaming room as a creative retreat

Have we sparked your interest?

Don't hesitate and submit your complete application documents online today.

We look forward to hearing from you!

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Kontakt
Kristof Wildmann

Arbeitsort
Kaiseraugst

Pensum
100%

Position
Mitarbeiter

Branche
Elektro + Mechanik