Betriebs-/Projektingenieur Qualifizierung

Overview

Operations/Project Engineer Qualification (m/f/d) in the field of Pharma Engineering Solida – 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 solids. 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 perfect candidate is communicative, has GMP experience and brings an understanding of the implementation of qualification in the pharmaceutical environment.

Responsibilities

• Creating qualification plans/reports for the DQ-IQ-OQ-PQ phases in accordance with the Roche Quality System.
• Carrying out qualifications in the DQ-IQ-OQ-PQ phases in accordance with the Roche Quality System.
• Creating QPPs/MQPs (Qualification Project Plans/Master Qualification Plans).
• Assessing technical changes to systems with regard to their impact on the qualified status and independently processing requalifications.
• GMP-compliant documentation of the work carried out and summarizing any differences that arise.
• Developing suggested solutions to any differences that arise.
• 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.
• Several years of experience in the GMP field with a deep understanding of quality systems and the lean implementation of GMP requirements.
• Good MS Office skills.
• Very good written and spoken German, good English skills.

Details

Reference No.:

Role: Operations/Project Engineer Qualification (m/f/d) in the field of Pharma Engineering Solida

Industry: Pharma

Location: Basel

Workload: 80-100%

Start: Asap (latest possible start date: )

Duration: permanent

Application deadline: 29/10/2025

How to apply

If this position has piqued your interest, please send us your complete application. If this position does not match your profile and you would like to apply directly for another position, you can also send us your application via this advertisement or to jobs(at)itcag(dot)com.

For more information about our company, our positions, or our attractive payroll-only program, please contact us: .

About us: ITec h Consult is an ISO 9001:2015-certified Swiss company with offices in Germany and Ireland. ITech Consult specializes in the placement of highly qualified candidates for temporary staffing in the IT, life sciences, and engineering sectors. We offer temporary staffing and payroll services. This is free of charge for our candidates, and we do not charge any additional fees for payroll either.

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