csv engineer in Basel

Lucie Nasshan, Basel Professionals Health Care & Life Sciences
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job details

basel, basel-stadt
Life Sciences
job type
reference number
lucie nasshan, basel professionals health care & life sciences
058 201 55 50
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job description

Randstad Professionals is currently looking for a CSV Engineer who will be assigned an interesting challenge for a major client based in the Basel Landschaft canton.

This contract is an unique opportunity to join a major client,lead player in the medical devices industry.

The initial assignment will start immediately and will last until December 2019

Your key responsibilities will include:

  • Computer Systems validation activities

  • Planning and implementation of qualification / validation activities and projects of new and existing

  • computer systems

  • Advisory and support of application owners to build and maintain GMP conform systems

  • Support and consulting during projects handling GxP critical computer systems

  • Creating specific computer system validation documentation

  • Know and follow the guidelines regarding the code of conduct, ethics and compliance programs and other relevant regulations

  • Planning and implementation of qualification / validation activities and projects of existing computer systems

  • Performing CSV trainings

Extended Duties :

  • Planning, coordination and execution of activities in cross-plant projects (eg. qualification of IT systems and infrastructure needs, validation of software, etc.).

The following skills are required:

  • Higher education (Engineer or similar) and background in IT and at least 3 years work experience

  • English and German fluent is a must

  • Responsibility in similar position or extended experience as executor required.

  • Knowledge of national and international regulations and standards is mandatory , eg. GAMP5, ISO 13485, ISO 62304, FDA QSR, 21 CFR Part 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 directly to the quality of the product or the quality system of the manufacturing.

  • Validation experience with ERP, MES, LIMS, and Quality Systems is preferred.