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Validation Engineer
hace 2 horas
BEPC has a Tijuana area OPEN POSITION for **Validation Engineer I - II **to join our fast-growing team of consultants
This role will be working on the shop floor to define the impact of the variant part and components, directly working with associates, group leaders and supervisors. Responsible for Assessments, Process validations, Software validations, Database updates, MFG related ECO’s (PI, MOP’s, SOP).
**KEY RESPONSIBILITIES**:
- Ability to manage projects, lead teams in different places performing projects.
- Write/Execute Process Validation Protocols (IQ, Create/Execute Engineering Changes Orders
- Write/Approve changes related to manufacturing documentation such as Manufacturing Work Instructions, BOM, router/traveler, etc.
- Troubleshoot process/ equipment malfunctions,
- Assessments, Process validations, Software validations, Database updates, MGF related ECO’s (PI, MOP’s, SOP).
**BASIC qualifications**:
BE/BS bachelor’s degree Communication skills
2+ years of medical devices experience.
Intermediate/ Advanced English level
Test methods development and validation
Lean and Six Sigma skills
Process validation
Design validation and verification
Knowledge in FDA
