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Design Validation Engineer
hace 3 semanas
About the Role
The Design Validation Engineer will be responsible for providing expertise and support to the Engineering Development Center (EDC) on all validation processes. This includes supporting hardware and software issues at the relabeling/Localization department and serving as the Global Labeling System Business Process Lead.
Your Responsibilities Will Include:
- Develop, implement, and manage a validation program to current FDA and GMP requirements.
- Act as Global Labeling System Business Process Lead.
- Provide timely hardware support to relabeling/Localization departments.
- Independently perform process, software, and/or equipment validation activities (IQ, OQ, PQ) and develop Master validation plans for new processes or update existing Master validation plans if required.
- Responsible for reviewing and developing process/software and equipment validation protocols and reports.
- Support other functional areas during validation activities.
- Assist EDC personnel in the creation of statistical sampling plans, inspection methodology, and quality procedures when required.
- Define gauges, tools, and equipment for test methods developed.
- Work cross-functionally with other departments to accomplish tasks.
What We Are Looking For:
- Bachelor's or Licenciature degree in Chemical, Materials, Mechanical, Electromechanical, Electronic, Industrial, Biomedical, Electrical, or Industrial Maintenance.
- English Level desired: B2+ 80-90%.
- Experience: At least 3 years.
- Technical Competencies: ASQ certification (desired).
- Problem Solving.
- Studies in product validation and verification.
- Knowledge of statistical methods.
- Knowledge of QSR's.
- Execution oriented.
- Quality oriented.
- Communication.
- Innovation.
