Job Description

Qualification Engineer in the field of Drug Substances (m/f/d) - Qualification Process / Systems and Rooms/Media / GMP / Data Integrity / German / English

Project:

For our client, a large pharmaceutical company based in Basel, we are looking for a Qualification Engineer in the field of Drug Substance (m/f/d).

Background:

Pharma Engineering is looking for suitable candidates with experience in plant qualification in the field of drug substance (API manufacturing). The work environment includes process plants, media, energy, and air conditioning systems such as reactors, fermenters, centrifuges, pure water, steam, autoclaves, clean rooms, and small parts washing machines.

The ideal candidate has experience in the qualification of production facilities and is familiar with the practical implementation of GMP guidelines. Changes and deviations are drafted flawlessly and presented confidently during regulatory inspections along with the facility qualification. Work and time management are self-organized and coordinated with the team and clients.

Tasks & Responsibilities:

Creation of qualification plans/reports for the DQ-IQ-OQ-PQ phases according to the Roche Quality System. Conducting qualifications in the DQ-IQ-OQ-PQ phases according to the Roche Quality System. Creation of QPPs (Qualification Project Plans). Evaluation of technical changes to systems with regard to their impact on the qualified status and independent processing of requalification activities. GMP-compliant documentation of the work performed and summary of any deviations that occurred. Development of proposed solutions for any deviations that occurred. Familiarization with electronic qualification and validation software.

Must-Haves:

Degree in a natural sciences/engineering program or relevant professional experience. At least 3 years of professional experience and solid experience in the qualification process. Practical professional experience with the qualification of various types of systems and rooms/media. Several years of experience in the GMP field with a deep understanding of quality systems and the lean implementation of GMP requirements. Initial experience with data integrity is desirable. Very good written and spoken German skills, good English skills.

Reference No.: 924468

Role: Qualification Engineer in the field of Drug Substance (m/f/d)

Industry: Pharma

Place of work: Basel

Workload: 80-100%

Start: Asap

Duration: 5 years

Application deadline: 10/10/2025

Job Type: 80-100%

Work Location: On the road