qualification engineer (high-purity media).

• Start Date: August - November 2026
• Duration: 1 year with likely extension
• Work Location: Basel and Kaiseraugst
• Workload: 80-100%
• Home Office: possible after onboarding (frequent onsite presence is preferred)
• Travel: occasional, for FAT activities
• Department: Technical Compliance
• Working Hours: Standard

About the Job:


As a Qualification Expert, you will work in the "Infra Qualification" Circle at our Basel/Kaiseraugst location which creates and maintains the GxP-qualified status of facilities, equipment and systems in the areas of "Infra & Logistics, QC & Labs."

The SPOC (Single Point of Contact) area of Infra Energy Operations manages facilities and systems for the generation and site-wide distribution of GMP media (purified water, nitrogen, and process air).

You will be responsible for creating qualification documentation in accordance with all internal and regulatory requirements and maintaining it according to our established processes. You will contribute your expertise to clarify and present technical GMP topics in a sustainable manner. Your daily tasks will also include interdisciplinary collaboration with our internal client groups.



Tasks & Responsibilities:
 

• Creating qualification documents and conducting qualifications according to the Quality System
• Assessing technical changes to equipment regarding their impact on the qualified status and independently handling requalification activities
• GMP-compliant documentation of the work performed and summarizing the deviations encountered
• Conducting qualification reviews
• Developing solutions to identified deviations
• Familiarization with electronic qualification and validation software (ELVIS)
• Supporting the creation of work instructions
• Participating in inspections and audits
• Possibly assuming support functions in the SPOC area (e.g., inventory management, SOPs, SPOC representation)

Must Haves:
 

• Completed vocational training/degree in one of the following fields: Automation, Mechanical Engineering, Process Engineering, Pharmaceutical Engineering, or Biotechnology
• Minimum 3 years of professional experience with qualifications in the plant engineering sector
• Extensive professional experience in a GMP-regulated work environment
• Excellent written and spoken German and English skills
• Good computer skills (e.g., Google Assistant, MS Office)

• CSV knowledge

Sounds interesting? Apply now – we’re looking forward to receiving your applications!