Senior Validation Engineer (SDLC) (Ciudad Juárez)

Senior Validation Engineer (SDLC) (Ciudad Juárez)

11 ago
|
BEPC Inc. - Business Excellence Professional Consulting
|
Ciudad Juárez

11 ago

BEPC Inc. - Business Excellence Professional Consulting

Ciudad Juárez

BEPC Inc. provides Specialized Engineering Solutions and IT Project Management services to Fortune 500 companies in the Life Science and Technology industries. BEPC Mexico, a division of BEPC Incorporated, provides and manages consulting services for Automotive and Medical device companies throughout Mexico and around the globe.

BEPC has a Ciudad Juarez area OPEN POSITION for Senior Validation Engineer to join our fast-growing team of consultants!

KEY RESPONSIBILITIES:

- Provide technical engineering support for validations, write, and execute Installation Qualification (IQ) protocols, and provide data to write completion reports for assigned validations.
- Provide technical engineering support for validations, write, and execute Operational Qualification (OQ) protocols, and provide data to write completion reports for assigned validations.
- Provide technical engineering support for validations, write, and execute Performance Qualification (PQ) protocols, and provide data to write completion reports for assigned validations.
- Develop, review, and execute Computer Software Validation (CSV) documentation aligned with SDLC principles.
- Ensure validation activities comply with Software Development Life Cycle (SDLC) requirements and regulatory standards.
- Experience using the ETQ platform for managing quality events,



including Nonconformances (NCRs), CAPAs, and quality-related activities.
- Provide technical engineering support for validations, write, and execute Test Method Validation (TMV) protocols.
- Provide technical engineering support for validations, write, and execute SAT (Factory Acceptance Testing) validation protocols, and provide data to write completion reports for assigned validations.
- Responsible for running experiments during the pre-validation phase, run other experiments as needed.
- Ensure that assigned validation activities are performed in a timely manner and in accordance with current requirements and Good Manufacturing Practices (GMP).
- Demonstrate sufficient knowledge in validation skills, GMP, Good Documentation Practices (GDP).
- Responsible for the execution of validation, including the creation of forms to create calibration and preventive maintenance records.

MAIN QUALIFICATIONS:

- Engineering Degree (master’s in science is a plus)
- 4 – 5 years of experience in medical industry
- Proven experience in Software Development Life Cycle (SDLC) validation.
- Experience working with ETQ plataform
- Good presentation skills before groups/clients.

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📌 Senior Validation Engineer (SDLC) (Ciudad Juárez)
🏢 BEPC Inc. - Business Excellence Professional Consulting
📍 Ciudad Juárez

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