Staff Software Validation Engineer (Medical Industry)

BEPC Inc. - Business Excellence Professional Consulting; Ciudad Juárez; Presencial; MXN 600.000 - 1.000.000; Jornada completa

Descripción de la vacante

BEPC Inc. Mexico is seeking a Staff Software Validation Engineer (CSV) to lead end-to-end validation across software, equipment, and computer systems in support of life science and automotive projects.

You will drive DOE development, Lean Six Sigma initiatives, and Validation documentation while collaborating with Operations, Design, and Engineering to ensure GMP-compliant products meet regulatory and design requirements.

Formación

• 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 to LIMS software.
• Expert with Software Validation and ability to draft URS, Test Protocols, and computer specifications.
• Expert with cross-functional collaboration across departments and multiple suppliers.
• MS Project and Project Management to manage validation action plans for multiple equipment.
• Strong presentation skills before groups/clients.
• Solid skills in developing Factorial Experiments (DOE).

Responsabilidades

• Lead and ensure on-time execution of validation projects.
• Execute and generate moderate to high complex validation documentation.
• Communicate updates to core teams and stakeholders.
• Maintain project metrics, weekly updates, and dashboards.
• Provide training sessions on validation processes and tools.
• Create Change Projects & Change Orders with proper documentation.
• Gather requirements and feedback for validation materials.
• Monitor status of validation activities and report to leadership.
• Support for IQ/OQ/PQ/CSV protocol development and data for completion reports.
• Run pre-validation experiments and other required tests.
• Ensure validation activities comply with GMP and GDP.
• Demonstrate knowledge of validation skills and Good Documentation Practices.
• Assist in development of production of new products.
• Analyze manufacturing functions and facilities to produce client products.
• Work with Operations and Design to verify regulatory and design requirements.

Conocimientos

Cross-functional collaboration

Software validation

DOE (Design of Experiments)

Presentation skills

Validation documentation

Educación

Engineering Degree

Master’s in science (preferred)

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.

RESPONSABILITIES:

• 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.
• Responsible for running experiments during the pre-validation phase, running 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.
• Support for the development of the production of new products.
• Responsible for the analysis and development of manufacturing functions, capabilities and facilities necessary to produce the client's product.
• Work with the Operations and Design team to verify and validate that the product under development meets regulatory and design requirements.

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
• Expert with Software Validation - should be able to draft, approve Software Validation documents - like URS, Test Protocol, Computer specifications etc.
• 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.
• Solid skills in developing Factorial Experiments (DOE).