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- Public sectorOur offerTo strengthen our team in Life Science, we are looking for a talented Consultant.
The Qualification and Validation Engineer will support and conduct validation studies, technology transfer activities, process characterization studies and gauge R&R studies within the Manufacturing Process.
This position will also provide guidance on the equipment / process validation requirements and design control activities for new product development projects.
Your roleSpecific responsibilities of the Qualification and Validation Engineer include, but are not limited to, the following : Support / conduct FAT / SAT and then IQ / OQ / PQ validation studies of equipment and processes, utilities and software validationsAdvise project teams, develop / review and approve validation protocols and final reportsManage Change Control on material specifications and documentation, develop and validate test method validation (Gage R&R)Support of continuous improvement on process, and on Qualification and Validations projectSupport on Non Conformity, CAPA, Internal audits and failure investigationsParticipate in project planning, scheduling, and trackingDevelop and implement procedures to comply with corporate and industry standardsProvide validation training to Opeations employeesYour profileEducation level : Msc, PhD in Engineering is required for this position.
Minimum 5 years of experience in Quality Engineering or Validation Engineering Candidates should also possess the following skills / experiences : Applied knowledge of FDA and international Pharmaceutical and or medical device regulations is preferredApplied knowledge of the application of Advanced Quality tools such as Failure Modes Effect Analysis (FMEA), SPC, Root Cause Analysis, etc.
Applied technical understanding of manufacturing equipment; processes specific to pharmaceutical and or medical device manufacturing preferredDemonstrated problem solving and troubleshooting skillsDemonstrated effective verbal and written communication skillsDemonstrated results orientation, ability to multi-task, quick learner, team player and demonstrated ability to respond to urgent needs and deliver expected results in a deadline driven environment Languages : French as well as English.
Ready to join? We offer an exciting tailored career path for your professional and personal development within an international company.
You will be accompanied from the beginning with specific coaching and mentoring programs and intensive training on innovation and management in a fast-moving and results driven environment.
We are looking forward to meeting you very soon at Altran!Job TitleQualification and Validation Engineer Life sciencesVacancy Reference Number02472Work SiteSwitzerland / CHE - All Regions / Lausanne