Nos offres d'emploi

Computerized/Automated System Validation Engineer


Suisse - Suisse Alémanique

CVO/CH/ING/1013

A Life Sciences specialist for over 20 years, CVO-EUROPE offers consulting, audit, and training services that are compliant with the regulatory requirements of the Chemical, Pharmaceutical, Biotechnology, Cosmetics, Food & Beverage, and Medical Devices industries.
With more than 350 consultants, CVO-EUROPE provides expertise in every activity that may affect patient health, product quality or data integrity.
CVO-EUROPE is an international group with business divisions in France, Belgium, Switzerland, and the USA.

To support our development, we are looking for :

Computerized/Automated System Validation Engineer

Permanent contract

Responsibilities

You will be involved in the implementation, evolution and reliability of the computerized or automated system for our life sciences customers. You coordinate and participate to the computerized system validation.



Your main tasks will be (not exhaustive list) to:

• Manage and coordinate IT quality projects (meetings, planning, monitoring validations activities),

• Define and put in place the validation strategy (VPL, Risk analysis),

• Advice or support the writing of specification documents (URS, FS, DS),

• Write the test protocols (IQ, OQ, PQ),

• Execute or supervise of the test execution,

• Support projects team on the CSV methodology,

• Write the IT SOP’s,

• Raise the awareness of users concerning the IT processes,

• Review the Quality of the IT documents,

• Manage the deviations and change control.


Qualifications/Skills

• You have an engineering degree or equivalent by experience,

• You have at least 3 years of experience in the information and automation systems (ERP, GPAO, MES, LIMS, PLC, SCADA…) or you have already participated in their implementation,

• You know the CSV and regulatory requirements (FDA, European…), norms and guidelines (GAMP, ITIL...),

• You speak fluently German and English. French is an asset,

• You are mobile, flexible and rigorous,

• Your social skills enable you to work in team.



We offer:
- The opportunity to develop your career within a people-oriented group operating at an international level, with the scope to get involved with challenging projects,

- Approachable management and a strong company culture that focuses on professional and personal fulfilment,

- A wide range of career development opportunities,

- Continuing professional development and personalised career management.


If you are looking for a satisfying career, full of rewarding and varied experiences, with the possibility for development, apply to join the team at CVO-EUROPE!

publication date : 18/12/2018

  1. Mrs Mr



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