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
- 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?
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!