Qualification Engineer; Temperature-Controlled Equipment​/Rooms

For one of our clients, a global pioneer in pharmaceuticals, we are currently looking for a Qualification Engineer (in the field of Temperature-Controlled Equipment / Rooms).

• Start Date: 24.08.2026
• Planned Employment Duration: 1 year with the possibility of extension
• Workplace: Basel and Kaiseraugst
• Home Office: Partially possible after the onboarding phase; presence on-site is preferred for the majority of the time
• Travel: Occasional travel for FAT (Factory Acceptance Testing) activities
• Team Size: Approx. 6 people
• Department: Technical Compliance (EFHC)
• Working Hours: Standard

The Infra Qualification unit is seeking suitable candidates with experience in equipment qualification, creating work instructions and process descriptions, and providing GMP consulting to internal clients. The work environment involves supporting temperature‑controlled equipment and rooms.

Holds a degree in automation, mechanical engineering, process engineering, pharmaceutical technology, or biotechnology. They bring at least three years of professional experience in equipment qualification
, alongside profound knowledge of a GMP-regulated environment
. CSV (Computer System Validation) knowledge is desirable. Furthermore,
very good written and spoken German
, as well as good English skills, are required.

• Creating qualification documents and executing qualifications in accordance with the Quality System.
• Assessing technical changes to equipment regarding their impact on the qualified state, and independently managing requalification activities.
• Documenting performed work in a GMP-compliant manner and summarizing any deviations encountered.
• Developing proposed solutions for deviations that occur.
• Familiarizing oneself with and using electronic qualification and validation software (ELVIS).
• Supporting the creation of work instructions.
• Participating in inspections and audits.
• If applicable, taking on supporting functions within the SPOC area (e.g., inventory maintenance, SOPs, SPOC deputy duties).

• Completed education/degree in one of the following fields:
  Automation, Mechanical Engineering, Process Engineering, Pharmaceutical Technology, or Biotechnology.
• At least 3 years of professional experience with qualifications in an equipment/plant environment.
• CSV (Computer System Validation) knowledge is desirable.
• Profound professional experience in a GMP-regulated work environment.
• Very good written and spoken German, as well as good English skills.

Application Submission Deadline: 07.07.2026