Software Validation Engineer (Medical Industry)

BEPC Inc. - Business Excellence Professional Consulting; Ciudad Juárez; Presencial; MXN 600.000 - 900.000; Jornada completa

Descripción de la vacante

BEPC Mexico, a division of BEPC Incorporated, seeks a Staff Software Validation Engineer (CSV) to lead end-to-end validation strategies across processes, equipment, and computer systems. You will drive DOE development and Lean Six Sigma initiatives while collaborating with Operations, Design, and Engineering teams to ensure regulatory and quality requirements are met.

The role requires 6–9 years in the medical industry, an Engineering degree, andexpertise in Software Validation and LIMS

Formación

• Engineering degree required; master’s in science a plus.
• 6–9 years of experience in medical industry.
• Expert with LIMS or connecting equipment to LIMS software.
• Expert with Software Validation and drafting Validation documents (URS, Test Protocols, etc.).
• Experience collaborating with cross-functional departments and multiple suppliers.
• Proficient in MS Project and project management to track validation actions.
• Strong presentation skills for client meetings.

Responsabilidades

• Lead validation projects and ensure on-time execution per plan.
• Generate and review complex validation documentation (IQ/OQ/PQ/CSV).
• Coordinate with DTx Core Team and site leadership on validation activities.
• Maintain project metrics, dashboards, and risk registers.
• Provide training on validation processes and tools to team members.

Conocimientos

Software Validation

LIMS integration

MS Project

Cross-functional collaboration

Educación

Engineering Degree

Master’s in science

Herramientas

LIMS software

MS Project

Descripción del empleo

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.

At BEPC Inc., we are looking for a Staff Software Validation Engineer (CSV) with deep expertise in end-to-end validation strategies, including process, equipment, computer systems, and maintenance validations. This role will lead DOE development, Lean Six Sigma initiatives, and project-level execution, while collaborating closely with Operations, Design, and Engineering teams to ensure products meet regulatory, quality, and design requirements.

RESPONSIBILITIES:

• Responsible for leading and ensuring on-time execution of Continuous Improvement Workstream #2 active projects as per commitment and plan.
• Execute and generate moderate to high complex validation documentation.
• Responsible for communicating and keeping track of the activities at the DTx Core Team, site leadership, business leadership stakeholders.
• Responsible of updating and keeping track of the project's metrics, weekly updates and site dashboards (PO Tracker, Project Timelines, Validation Documentation Tracker, Risk Register and KPI Tracker).
• Provide training sessions for team members and stakeholders on validation processes and tools.
• Create and submit Change Projects & Change Orders (COs) ensuring proper documentation and approval processes are followed.
• Collaborate with team members to gather requirements and feedback for validation of documentation and training materials.
• Monitor and report on the status of validation activities and Change Orders to the project lead, site leadership and business leadership stakeholders.
• 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.
• Provide technical engineering support for validations, write, and execute Computer Systems Validation (CSV) protocols.
• 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.

QUALIFICATIONS:

• Engineering Degree (master’s in science is a plus)
• 6 – 9 years of experience in medical industry
• Expert with LIMs or Expert in connecting equipment's to LIMs software (Desirable)
• Expert with Software Validation - should be able to draft, approve Software Validation documents - like URS, Test Protocol, Computer specifications etc. (Must)
• Expert with working/collaborating Cross functional departments, multiple suppliers.
• Expert with MS project, Project Management - be able to Manage/track action plans for multiple equipment validation
• Good presentation skills before groups/clients.