Betriebs-/Projektingenieur Qualifizierung

Operations/Project Engineer Qualification (m/f/d) in the field of Pharmaceutical Engineering Solids - Qualification Process / GMP / Quality Systems / German / English

Project : For our client, a large pharmaceutical company based in Basel, we are looking for an Operations/Project Engineer Qualification (m/f/d).

Background :
Pharma Engineering is seeking suitable candidates with experience in plant qualification in the field of pharmaceutical engineering for solid dosage forms. The work environment includes process plants, media, energy systems, and air conditioning systems such as reactors, fermenters, centrifuges, purified water, steam, autoclaves, cleanrooms, and small parts washing machines.

The perfect candidate is communicative, has GMP experience and an understanding of how to implement qualification in the pharmaceutical environment.

Tasks & Responsibilities:
• Creating 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.
• Creating QPP/MQP (Qualification Project Plan/Master Qualification Plan).
• Evaluating technical changes to equipment regarding their impact on the qualified status and independently processing requalifications.
• Documenting the work performed in accordance with GMP and summarizing any discrepancies.
• Developing solutions to any discrepancies that occurred.
• Learning to use electronic qualification and validation software.

Must-haves:
• Degree in a natural science/engineering field or relevant professional experience.
• Minimum of 3 years of professional experience and sound experience in the qualification process.
• Several years of experience in the GMP field with an in-depth understanding of quality systems and the lean implementation of GMP requirements.
• Good MS Office skills.
• Excellent written and spoken German skills, good English skills.

Reference No.: 924516
Role: Operations/Project Engineer (m/f/d) in Pharmaceutical Engineering, Solid Substances
Industry: Pharmaceuticals
Location: Basel
Workload: 80-100%
Start: ASAP
Duration: Permanent
Application Deadline: 23/11/2025

Should this position have sparked your interest, please send us your complete application. If this position isn't quite the right fit and you'd prefer to be notified about other opportunities, you can also submit your application via this advertisement or to jobs[at]itcag[dot]com.
For more information about our company, our open positions, or our attractive payroll-only program, please contact us at +41 41 760 77 01.
About us:
ITech Consult is an ISO 9001:2015 certified Swiss company with offices in Germany and Ireland. ITech Consult specializes in placing highly qualified candidates for temporary staffing in the IT, Life Science, and Engineering sectors. We offer both temporary staffing and payroll services. These services are free for our candidates, and we do not charge any additional fees for payroll.