Validation Engineer – Software Validation - Chihuahua - BEPC Inc. - Business Excellence Professional Consulting

    BEPC Inc. - Business Excellence Professional Consulting
    BEPC Inc. - Business Excellence Professional Consulting Chihuahua

    hace 1 día

    Descripción

    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.

    We are seeking a Validation Engineer – Software Validation (Automation) with strong experience in industrial automation systems, PLC-based equipment, and validation documentation within regulated environments. The ideal candidate will support and lead validation activities for software-controlled automated systems, ensuring compliance with applicable regulatory requirements and internal quality standards.

    KEY RESPONSIBILITIES:

    • Lead and support validation activities for software-controlled automated equipment and systems, ensuring compliance with medical device regulations and internal quality standards.
    • Develop, review, and execute validation deliverables including URS, Risk Assessments, IQ/OQ/PQ protocols, test scripts, and validation reports.
    • Ensure appropriate traceability from requirements to testing through a Traceability Matrix and evidence collection.
    • Program, troubleshoot, and support industrial automation systems using Allen Bradley and Siemens PLCs.
    • Validate automation functionality including PLC logic, HMI/SCADA interfaces, alarms, interlocks, recipes, and system security where applicable.
    • Integrate and validate automation components such as vision systems, sensors, and communication interfaces (e.g., Ethernet/IP, Profinet).
    • Support investigations, deviations, and remediation activities related to automation and validation (e.g., CAPA, change control, revalidation).
    • Collaborate with Manufacturing, Quality, IT, Engineering, and Maintenance to ensure equipment readiness and validated state is maintained.
    • Participate in continuous improvement initiatives to enhance system reliability, efficiency, and compliance.
    • Provide technical support and training to operations and maintenance teams on validated systems and procedures.
    • Ensure adherence to safety, quality, and regulatory requirements (e.g., FDA, ISO 13485, and applicable GMP standards).

    QUALIFICATIONS:

    • Bachelor's degree in Electrical Engineering, Mechatronics, Automation, Software Engineering, or related field.
    • Indispensable 3–5 years of experience in validation and/or automation engineering roles within regulated industries (medical device).
    • Hands-on experience with PLC-based automation systems (Allen Bradley and/or Siemens).
    • Experience generating and executing validation protocols such as IQ/OQ/PQ, including testing and documentation practices.
    • Knowledge of HMI development and SCADA systems and their validation considerations.
    • Familiarity with vision systems and integration/validation of sensors and inspection systems.
    • Strong understanding of documentation control, traceability, and compliance requirements.
    • Strong analytical, troubleshooting, and problem-solving skills.
    • Intermediate to advanced English proficiency (written and verbal).

    PREFERRED QUALIFICATIONS:

    • Familiarity with Computer System Validation (CSV) concepts and best practices.
    • Knowledge of GAMP 5, 21 CFR Part 11, and data integrity principles (ALCOA+), if applicable.
    • Experience with validation in manufacturing equipment such as assembly machines, inspection systems, testers, or packaging automation.
    • Experience supporting audits and regulatory inspections.

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