Validation Engineer Process Development
Flexible & Integrated Technical Services
- Dorado, PR
- Permanente
- Tiempo completo
- Bachelor Degree in Engineering and three (3) years of in the medical devices industry.
- Bilingual: English and Spanish
- Skills: Writing Skills
- Shift: Administrative, and according to business needs.
- Experience in:
- Process and/or equipment validation activities (IQ, OQ, PQ).
- Responsible for reviewing and developing process validation protocols and reports.
- Automation systems testing.
- Process Development and/or Manufacturing Process Engineering.
- Support process and/or equipment validation activities (IQ, OQ, PQ); process performance qualification activities, and develop Master validation plans for new processes or products.
- Responsible for reviewing and developing process validation protocols and reports. Support other functional areas during the validation activities.
- Work with the Process Development team to efficiently qualify new processes; assist with statistical sampling plans, and other development procedures.
- Design and develop in-process and receiving quality systems for new processes and components.
- Generate equipment documentation, such as equipment entries, evaluations, PM, and calibration procedures, as required.
- Define gages, tools, and equipment for the test methods developed.
- Generate manufacturing instructions for new processes being developed.
- Work cross-functionally with other departments to accomplish PD tasks.
- Assures that appropriate resources (personnel, tools, etc.) are maintained to assure Quality System compliance and adherence to the BSC Quality Policy.
- Establishes and promotes a work environment that supports the Quality Policy and Quality System.