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)
Soft skills
* 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 !
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