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About us
At Capgemini Engineering Switzerland we value excellence, diligence, responsibility, dynamism and innovation. We offer a diverse workplace and would like to invite you to be part of our success story where we provide training, tools and foundations for your professional and personal growth. We are looking for an experienced Pharma/Biotech CQV Engineer.
Job description
- 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 Operations employees
Your profile
- Msc, PhD in Engineering is required for this position
- Minimum 5 years of experience in Quality Engineering or Validation Engineering
- 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 effective verbal and written communication skills
- Demonstrated problem solving and troubleshooting 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
Benefits:
- Between 30% and 70% remote work in agreement with your manager and client needs (40% for cross boarders due to tax regulation)
- Options to order ergonomically proven equipment (monitor & chair) for your home-office premises
- Support for trainings, formation upon agreement with the manager
- Contribution on gym subscription
- Trust-based managerial culture
- Team rituals and get togethers
We look forward to receiving your application. Capgemini Engineering only accepts direct applications (no recruitment agencies). Due to Swiss regulations we only consider Swiss or EU/EFTA applicants or applicants with a valid work permit.
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