Qualification engineer

Qualification Engineer: Qualifications / Validation Software / CSV / Automation / Process Engineering / Pharmaceutical Engineering / Biotechnology / Plants / GMP / / German / English

Project: For our client, based in Basel, we are looking for a qualification engineer.

Background: The Qualification team is seeking suitable candidates with experience in plant qualification, creating work instructions and process descriptions, and providing GMP consulting to internal clients. The work environment includes the maintenance of temperature-controlled systems/rooms.

Tasks & Responsibilities:

-Creating qualification documents and conducting qualifications.

-Assessment of technical changes to plants with regard to their impact on the qualified condition and independent handling of requalification activities.

-GMP-compliant documentation of the work performed and summary of any deviations that occurred.

-Conducting qualification reviews.

-Development of proposed solutions to the deviations that have occurred.

-Training in electronic qualification and validation software (ELVIS).

-Support in creating work instructions.

-Participation in inspections and audits.

-Taking on supporting functions in the SPOC area (e.g., inventory management, SOPs, SPOC representation).

Must Haves:

-Completed vocational training / studies in one of the following fields: Automation, Mechanical Engineering, Process Engineering, Pharmaceutical Engineering or Biotechnology

-3 years of professional experience with qualifications in the plant engineering sector

-CSV knowledge is desirable.

-Extensive professional experience in a GMP-regulated work environment

-Excellent German skills, both spoken and written, as well as good English skills.

-Good computer skills (e.g., Google software suite, MS Office)

Role: Qualification Engineer

Location: Basel & Kaiseraugst

Workload: 80–100%

Start: (August 24, 2026) (Latest possible start date: November 1,2026)

Duration: 12+ Months

Application Deadline: July 6,2026