Senior Validation Engineer

For our customer in Solothurn we are looking for a project ASAP for a Senior Validation Engineer

Tasks and 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 an 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)

Requirements/Qualification:

- Knowledge of the standard family ISO 10993-1
- Experiences of Good Manufacturing Practice (GMP)
- Background in process and cleanliness validation
- Proficient with MS Office Tools (Word, Excel) as well as SAP
- 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: German: native, English: fluent.

Are you interested in this position? Then we are looking forward to receive your application.