Work SiteSwitzerland / | CHE - All Regions / Zürich
Contract TypePermanent [Full-Time]
Minimum number of years of experience required5 years of experience and more
Our offer
A permanent contract with the leader in innovation and high-tech engineering consulting.
A multi-stage model with career opportunities through specialization prospects, as well as with over 45'000 consultants around the world and revenue of EUR. 2.9 Bn, the Altran Group is the undisputed global leader in Engineering and R&D services (ER&D).
In Switzerland, Altran employs more than 250 consultants and aims towards large growth with offices located in Zürich, Basel, Lausanne and Geneva.
Altran deploys its expertise particularly in Life Sciences (Pharma, Biotech, and Medical Devices); Industry, Aerospace, Automotive, Energy, Railways; Financial Services: P&C Insurance, Health Insurance, Reinsurance, Banking; Telecoms and Public sector.
Your role
Independent implementation and documentation of validation and qualification activities in accordance with valid specifications and project planning, in close cooperation with internal and external partners / interfaces of Operations Instrumentation, in particular for the areas of instrumentation and all custom-made systems of the tech support department.
Co-responsible for ensuring compliance in accordance with the applicable internal guidance documents. Review of validation / qualification documents, checking for correctness of form and content.
Creation of validation / qualification plans and reports, as well as test plans / reports.
Planning and execution of validation and qualification tasks, as well as maintenance of the existing qualification documentation.
Qualification of equipment, like standard equipment, custom built systems or measuring equipment.
Validation of test sites (custom built, consisting of various subsystems including software components).
Validation of software and Excel workbooks, according to CSV (computerized system validation).
Support and expert advice to operators and the user of equipment / systems when performing validation and qualification tasks
Reporting, coordination and coordination of priorities with clients, partners / interfaces such as Sub-project leader, Product Leader, Line Manager and contact person from the specialist departments.
Collaboration in the preparation of risk analyses of equipment / systems.
Your profile
Bachelor of Science in Engineering, Science or Medical Technology.
Very good understanding of complex processes in test processes and software functions.
Good maths skills to independently calculate the formulas of the software in Excel based on raw data, trends & correlations.
High technical understanding of test / process flows, and software functions to hard - / Software architectures are prerequisites for writing software test plans based on specifications.
EDP knowledge (SAP, MS Office) and understanding of hardware and software architectures are an advantage.
Experience in the regulated GxP environment, ideally the medical technology (ISO 13458, GMP, FDA 21 CFR 820).
Good comprehension, recognition of complex relationships, high quality awareness and a structured, systematic approach.
Great communication skills, information flow, coordination of different stakeholders.
Outstanding communication skills in English and German (compulsory).
