Computer System Validation (CSV) Engineer
- Employer
- CK Group
- Location
- Canton of Ticino, Switzerland
- Salary
- 85 - 95 CHF per hour
- Closing date
- Jan 18, 2018
View more
- Sector
- Science, Computer Science and IT, Computer Science, Life Sciences, Physical Sciences and Engineering
- Contract Type
- Contract/Freelance
- Hours
- Full Time
- Organization Type
- Corporate
- Jobseeker Type
- Professional
Job Details
Jocelyn at CK Science is currently recruiting for a Computer System Validation (CSV) Engineer to join an innovative medical device manufacturer based in Ticino, Switzerland.
This role is offered on a full time temporary basis for 3 months, with the possibility of extension.
Your main responsibilities in this role will be to:
• Implement qualification / validation activities and projects of new and existing computer systems according to internal and external requirements for all departments
• Complete computer system validation
• Provide advice and support of application owners to build and maintain GMP conform systems
• Support and consult during projects handling GxP critical computer systems
• Understand and follow the guidelines regarding the code of conduct, ethics and compliance programs and other relevant regulations
• Performing CSV trainings
• Ensure computer systems are installed according to companies Software Development Lifecycle
• Execute activities in cross-plant projects (eg. qualification of IT systems and infrastructure needs, validation of software, etc.)
You are required to have the following qualifications, skills and experience:
• Higher education (Engineer or similar) and background in IT (or equivalent)
• Previous experience within a similar management position or experience as an Executer is desirable
• Knowledge of national and international regulations and standards, eg. GAMP5, ISO 13485, ISO 62304, FDA QSR, 21 CFRPart 820, Part 11
• Experience in CSV system development life cycle is required
• Background in Quality Systems is required, as the procedures to revise are related
• Validation experience with ERP, MES, LIMS, and Quality Systems is preferred
• Italian and English spoken and written is desirable
If you are employed by this client you will be joining a global healthcare organisation based in Switzerland.
For more information or to apply for this Computer System Validation (CSV) Engineer position please contact Jocelyn on +44 (0)1438 723 500 or email jblackham@ckengineers.co.uk. Alternatively, please click on the link below to apply online now.
CK Science is an Equal Opportunities employer who welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference ST40856 in all correspondence.
Company
Here at CK, our passionate nationwide team are all specialists in recruitment and strive to deliver a world-class service through our separate tailored divisions.
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