Beschreibung
Validation Engineer Cleanliness
Responsibilities:
- compile a traceable process validation documentation for medical devices in respect of cleanliness and biocompatibility
-support the manufacturing sites implementing the biocompatibility and cleanliness process
-prepare the complete and traceable electronic documentation of the cleanliness validation and Biological Safety Evaluation (part of the Device Master Record (DMR)
-review and incorporation of manufacturing process validation and test data into documentation management systems
-assess the cleanliness and biocompatibility status of existing manufacturing processes (with support of further subject matter experts)
-responsible of the conduct of the cleanliness validation in manufacturing
-coordination of externals cleanliness tests in cooperation with a internal unit (eg Cytotoxicity, Bioburden, Fourier Transform Infrared Spectroscopy (FTIR), Total Organic Carbon (TOC)
-documentation of process monitoring processes regarding cleanliness
-interface between different functions (manufacturing, process validation, material testing, risk management)
Further qualification:
-knowledge of the standard family ISO
-experiences of Good Manufacturing Practice (GMP)
-background in process and cleanliness validation
-proficient with MS-Office Tools (Word, Excel) as well as SAP
Special working conditions:
-place of work at different manufacturing sites in Switzerland, travel to Southern Germany and Austria necessary (appr. 30%)
Non-Technical profile requirements:
- Some flexibility in working hours is required
- Must be able to work on multiple simultaneous tasks with limited supervision;
- Quick learner, motivated self-starter;
- Excellent customer service, interpersonal, communication and team collaboration skills;
- Able to follow change management for internal guidelines. Language proficiencies:
- English and Swiss German spoken and written
Bei Interesse und wenn Sie nachweislich in den letzten Projekten in diesem Umfeld gearbeitet haben, freuen wir uns über die Zusendung Ihres aussagekräftigen Profils/CV/Projektliste im Word-Format.
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Für Rückfragen stehe ich Ihnen gerne telefonisch zur Verfügung.
Viele Grüße
Frank Arnold
Recruitment Consultant
Michael Bailey International is acting as an Employment Business in relation to this vacancy.