Software Validation Engineer III

hace 5 días

Juárez, Chihuahua, México BEPC Inc. - Business Excellence Professional Consulting A tiempo completo

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.

The
Validation Engineer III
will support Independence projects by generating Asset Management documentation and executing validation activities within JIRA, including ThinManager and Cybersecurity implementation. This role plays a key part in ensuring systems, processes, and technologies comply with established validation and quality standards throughout the project lifecycle.

KEY RESPONSABILITIES:

  • Develop, review, and execute Computer Software Validation (
    CSV
    ) documentation in accordance with
    SDLC
    principles.
  • Generate and maintain Asset Management documentation aligned with project and quality requirements.
  • Perform and document User Acceptance Testing (
    UAT
    ) activities.
  • Execute validation tasks and workflows using
    JIRA
    .
  • Conduct and document Computer System Change Assessments (CSCA).
  • Support validation activities for Operational Technology (OT) systems.
  • Ensure validation deliverables meet internal quality standards and client requirements.
  • Collaborate cross-functionally with Engineering, IT, OT, Quality, and Cybersecurity teams.
  • Provide timely status updates and escalate risks or issues to the Project Manager when needed.

QUALIFICATIONS:

  • Bachelor's degree in Engineering, Computer Science or a related field
  • 5+ years of experience in validation, CSV, or regulated environments (medical device, pharmaceutical, or similar industries preferred).
  • Strong knowledge of Software Development Life Cycle (
    SDLC
    ).
  • Proven experience in Computer Software Validation (CSV).
  • Hands-on experience with User Acceptance Testing (UAT).
  • Experience performing Computer System Change Assessments (CSCA).
  • Knowledge and experience in Operational Technology (OT) environments.
  • Experience using
    JIRA
    for validation execution and documentation.
  • Intermediate level of English (reading and writing) and intermediate English conversation skills.

SOFTSKILLS:

  • Strong teamwork and collaboration skills.
  • Proactive mindset with the ability to work independently.
  • Positive attitude and solution-oriented approach.

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