Software Validation Engineer

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

Descripción de la vacante

BEPC Inc. seeks 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 leads DOE development, Lean Six Sigma initiatives, and project execution while collaborating with Operations, Design and Engineering to ensure products meet regulatory, quality and design requirements. Responsibilities include leading validation documentation, IQ/OQ/PQ/CSV protocols, change

Formación

• Engineering degree; master's in science is a plus.
• 6–9 years of experience in medical industry.
• Expert with LIMS or linking equipment to LIMS software.
• Expert in Software Validation; able to draft/approve URS, Test Protocols, etc.
• Experience collaborating across cross-functional departments and multiple suppliers.
• Proficient in MS Project and project management; manage multiple validations.
• Strong presentation skills for groups/clients.
• Solid experience in DOE (factorial experiments).
• Bilingual.

Responsabilidades

• Lead and ensure on-time execution of Continuous Improvement Workstream #2 projects.
• Execute and generate moderate to high complexity validation documentation.
• Communicate activities to DTx Core Team, site leadership, and stakeholders.
• Update project metrics, weekly updates, and dashboards.
• Provide training sessions on validation processes and tools.
• Create and submit Change Projects & Change Orders with proper documentation.
• Collaborate to gather requirements and feedback for validation docs and training materials.
• Monitor status of validation activities and Change Orders.
• Provide engineering support for IQ protocols and data to completion reports.
• Provide engineering support for OQ and PQ protocols and reports.
• Provide engineering support for CSV protocols.
• Run pre-validation experiments and other experiments as needed.
• Ensure validation activities comply with GMP and GDP.
• Execute validation and create calibration/maintenance records.
• Support development of production of new products.
• Analyze/manufacturing functions and facilities to produce the client's product.
• Verify regulatory and design requirements with Operations and Design teams.

Conocimientos

LIMS integration

Software Validation

DOE

Cross-functional collaboration

Documentation writing

Presentation skills

Educación

Engineering Degree

Master’s in Science (plus)

Herramientas

MS Project

LIMS software tools

Descripción del empleo

BEPC Inc. provides Specialized Engineering Solutions and IT Project Management services to Fortune 500companies 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 designrequirements.

KEY 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.
• 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.

MAIN 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).
• Bilingual