Qualification and Validation Engineer Life sciences

☞ Capgemini Engineering

View: 162

Update day: 21-03-2024

Location: Lausanne Vaud VD

Category: Quality Assurance / Quality Control

Industry: IT Services IT Consulting

Position: Entry level

Job type: Full-time

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Job content

To 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.Specific 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 validations
  • Advise project teams, develop/review and approve validation protocols and final reports
  • Manage 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 project
  • Support on Non Conformity, CAPA, Internal audits and failure investigations
  • Participate in project planning, scheduling, and tracking
  • Develop and implement procedures to comply with corporate and industry standards
  • Provide validation training to Opeations employees
Education 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 preferred
  • Applied 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 preferred
  • Demonstrated problem solving and troubleshooting skills
  • Demonstrated effective verbal and written communication skills
  • Demonstrated 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?Capgemini Engineering will be on the forefront in creating an optimal work-life balance, more autonomy in where and how our people work and to embrace the learnings we have experienced from wider-scale remote working. For you, this may mean less time in the office than usual with some time working from home, whereas other roles and engagements will continue to be more location-dependent or office-based. Together with your manager, you will agree an approach which works for you, your team and our business.In order to deploy this novel way of working, we have introduced our New Normal policy which includes:
  • 30% to 70% remote work in agreement with your line manager and client needs
  • Trust-based managerial culture
  • Team rituals and get togethers
  • Options to order ergonomically proven Equipment (monitor & chair) for your home office premises.
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Deadline: 05-05-2024

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