Qualification Engineer

Qualification Engineer

We are seeking a dedicated professional to support the qualification of Embedded Systems—automated production facilities such as SCADA/HMI systems.

Responsibilities

• Plan and execute qualification and validation activities for Embedded Systems.
• Create and review qualification documentation (DQ, IQ, OQ, PQ).
• Conduct and document qualification processes in compliance with cGMP standards.
• Develop and implement test strategies, plans, and cases to ensure system performance and regulatory compliance.
• Provide expertise in drafting specifications such as URS.
• Collaborate with IT, process engineering, automation, QA, and production teams to ensure seamless system integration and qualification.
• Perform qualification impact assessments related to changes or deviations.
• Support the handling of deviations, changes, and CAPAs.
• Maintain close communication and collaboration across departments.

Must-Haves

• Technical degree in a relevant field.
• Advanced training and hands-on experience in GMP environments.
• 3–5 years of experience in qualification and validation of machines and processes, ideally in the pharmaceutical industry.
• Strong hands-on experience in qualification activities.
• Familiarity with CSV and automation systems.
• Experience with Siemens COMOS, EVAL (ValGenesis), and VIVA is a plus.
• Fluent in German (spoken and written); strong English reading and writing skills.
• Start Date: ASAP
• Duration: 12 months (extension possible)
• Location: Kaiseraugst (up to 20% remote work)

If you want to learn more about this opportunity please feel free to reach out directly to mbertrand@actalentservices.com

*While we appreciate every application, please note that due to the high volume of responses, we may only be able to contact shortlisted candidates.