Qualification & Projects Engineer (all genders) - Fixed-term contract until 30.04.2027 - Inklus[...]

Sanofi-Aventis Deutschland GmbH; Frankfurt; Vor Ort; EUR 50.000 - 80.000; Vollzeit

Zusammenfassung

A leading pharmaceutical company is seeking a Qualification & Projects Engineer for Clean Utilities at their Frankfurt campus. The role involves defining technical requirements, managing projects, and collaborating with production teams to optimize clean utilities processes. Candidates should have an advanced engineering degree and extensive experience in the pharmaceutical sector.

Qualifikationen

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

Aufgaben

• Define technical and process requirements for clean utilities systems.
• Manage smaller projects on clean utilities facilities independently.
• Drive change control processes and qualification activities.

Kenntnisse

Communication skills

Teamwork

Flexibility

Problem-solving

Diligence

Ausbildung

Advanced degree in engineering

Jobbeschreibung

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

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