Step into a pivotal role at a global CMO and help shape the future of healthcare manufacturing.
Proclinical is seeking a CQV Engineer to join our client's team on a contract basis. In this capacity, you will lead efforts in equipment and facility validation, helping to streamline operations and optimize system functionality. Your expertise will ensure that engineering teams and facility personnel maintain the necessary technical knowledge.
Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.
Responsibilities:
1. Develop commissioning and qualification documentation for new installations and manage projects involving modifications and new constructions.
2. Oversee deviations, changes (GEP and GMP), and CAPAs.
3. Coordinate with internal teams and external service providers and suppliers.
4. Present qualification documents during audits and inspections.
Key Skills and Requirements:
5. Technical school diploma or university degree.
6. Experience in commissioning, qualification, and validation within a regulated environment, such as cooling and freezing equipment, clean media, and process equipment.
7. Ability to work independently and flexibly with strong communication skills; organized and open to new ideas.
8. Proficiency in Microsoft Office; familiarity with COMOS, DMS, TrackWise, and SAP is advantageous.
9. Fluent in German and proficient in English.