Validation Engineer

hace 2 semanas

Juárez Chih, México IngenioRx A tiempo completo

Perform characterization studies and DOE’s (as required).
- Develop validation strategies
- Write/Submit/Execute IQ (Installation Qualification) /OQ (Operational Qualification) /PQ (Performance Qualification) and TMV (Test Method Validation) protocols and submit to the document management system for approval.
- Procure the required materials for validations (if required).
- Coordinate the execution of validations with operations.
- Software validation (as required).
- Closeout validation activities.
- Write Test Reports and submit in the applicable Quality Documentation Management System for approval.
- Provide technical support and engineering troubleshooting as required to Operations.
- Write or modify the following documents: PFD, PI, MOP, EPR, and CAL (as required).
- Evaluate new Equipment as required.
- Support on CAPA (Corrective Action / Preventive Action) /NCR (Non-Conforming Request) / NCC (Non-Conforming Corrections) action item activities to expedite on-time completion

**Job Types**: Full-time, Contract

Pay: $50,000.00 - $70,000.00 per month

Application Question(s):

- How many years of knowledge of ISO13485 and GMP's (Good Manufacturing Practices) do you have?

**Education**:

- Bachelor's (required)

**Experience**:

- IQ, OQ, PQ Validations: 3 years (required)
- Microsoft Office: 1 year (preferred)
- Protocol Writing: 2 years (required)
- Medical Device Validation: 1 year (required)

**Language**:

- English (required)
- Spanish (preferred)

Work Location: In person

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