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Qualification & Projects Engineer (all genders) - Fixed-term contract until 30.04.2027

Sanofi-Aventis Deutschland GmbH

Frankfurt

Vor Ort

EUR 60.000 - 80.000

Vollzeit

Vor 4 Tagen
Sei unter den ersten Bewerbenden

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Zusammenfassung

A leading pharmaceutical company seeks a Qualification & Projects Engineer for Clean Utilities in Frankfurt. This role involves defining technical requirements and managing projects in pharmaceutical manufacturing. Candidates should possess an advanced engineering degree and relevant industry experience, and they will be key in driving optimizations in production facilities.

Qualifikationen

  • Several years of professional experience in the pharmaceutical industry.
  • Knowledge of FDA and cGMP regulatory requirements.
  • Experience in qualification and/or validation projects.

Aufgaben

  • Define technical and process requirements for clean utilities systems.
  • Drive change control processes and manage smaller projects.
  • Collaborate with production sites for improvements.

Kenntnisse

Communication
Result orientation
Flexibility
Team orientation
Problem-solving

Ausbildung

Advanced degree in engineering

Tools

GxP documentation

Jobbeschreibung

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Qualification & Projects Engineer (all genders) - Fixed-term contract until 30.04.2027, Frankfurt

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Client:
Location:

Frankfurt, Germany

Job Category:

Other

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EU work permit required:

Yes

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Job Reference:

21f79524f224

Job Views:

2

Posted:

23.06.2025

Expiry Date:

07.08.2025

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Job Description:

About the job

Our Team:

The ICF Eng Clean Utilities Team operates highly utilized pharmaceutical production facilities for drug product production for the Frankfurt campus.

We work closely with the different production units being supplied and coordinate any changes on our facilities with them.

Independence, diligence, good communication skills, flexibility, teamwork, and commitment are absolutely essential to mastering our daily challenges.

Main responsibilities:

  • As a Qualification & Projects Engineer for Clean Utilities you will be responsible for defining the technical and process requirements for clean utilities systems, as well as providing support during the design, implementation and qualification phases.
  • The focus is on changes of clean utilities facilities and processes: generation & distribution of water for injection, pure steam and technical gases
  • Driving change control processes and qualification activities
  • Managing smaller projects on clean utilities facilities independently
  • Creation of qualification plans, testing documents and lifecycle documentation
  • Managing existing facility life cycle documentation
  • Collaborate with production sites to identify improvements and lead optimization projects as needed.

About you

Education and experience:

  • advanced degree in engineering (e.g. mechanics, mechatronics, electronics, automation)
  • Several years of professional experience in the pharmaceutical industry
  • Knowledge of FDA and other regulatory requirements such as cGMP
  • Experience in the implementation of qualification and/or validation projects (CSV)
  • Willingness for transversal cooperation across functional boundaries / departments
  • Active driving of changes / optimizations in the area of delegation
  • Result and solution orientation, willingness to assume responsibility
  • Team orientation / team player with excellent communication skills
  • Self-reliant and systematic way of working
  • High willingness to communicate and ability to work in a team

Technical skills:

  • Good process and systems knowledge of the CMO and Sanofi Device Business.
  • Proven expertise in pharmaceutical manufacturing, GxP documentation and related Equipment Qualification and Process Validation of high throughput equipment.

Languages

  • Fluent in German and english knowledge is a plus

Pursue Progress. Discover Extraordinary.

Progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let's pursue progress. And let's discover extraordinary together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

#Engineering #Mechanic #Electronics #Automation #LI-Onsite

Diversity und Inklusion sind in den Grundwerten von Sanofi verankert und spiegeln sich in unserer Arbeitsweise wider. Wir respektieren die Vielfalt unserer Belegschaft in Hinsicht auf ihre Herkunft, Erfahrungen und Lebensweisen. Wir erkennen die Bereicherung, die diese Vielfalt birgt, und fördern Inklusion sowie eine Arbeitsumgebung, in der diese Unterschiede sich weiter entwickeln können, zur Stärkung des Lebens unserer Mitarbeiter, Patienten und Kunden.

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