Ingeniero de Validacion Staff IT (LIMS)

BEPC Inc. - Business Excellence Professional Consulting; Ciudad Juárez; Presencial; MXN 864.000 - 1.056.000; Jornada completa

Descripción de la vacante

BEPC Inc. Mexico, a division of BEPC Incorporated, seeks a Staff Software Validation Engineer (CSV) to drive end-to-end validation strategies across process, equipment, computer systems, and maintenance validations.

You will lead DOE development, Lean Six Sigma initiatives, and project-level execution while collaborating with Operations, Design, and Engineering to ensure regulatory, quality, and design requirements are met.

Formación

• Engineering degree; 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 - 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 - manage/track action plans for multiple equipment validation
• Good presentation skills before groups/clients.
• Solid skills in developing Factorial Experiments (DOE).

Responsabilidades

• Lead and ensure on-time execution of Continuous Improvement Workstream #2 projects.
• Execute and generate moderate to high complex validation documentation.
• Communicate status to DTx Core Team and stakeholders.
• Update project metrics and site dashboards (PO Tracker, Timelines, Validation Documentation Tracker, Risk Register, KPI Tracker).
• Provide training sessions on validation processes and tools.
• Create and submit Change Projects & Change Orders with proper documentation.
• Collaborate to gather requirements/feedback for validation materials.
• Monitor validation activities and report to project lead and leadership.
• Provide technical support for validations and write IQ/OQ/PQ/CSV protocols and completion reports.
• Support development of production of new products.
• Verify product meets regulatory and design requirements.

Conocimientos

Software Validation

DOE

MS Project

Regulatory GMP

LIMS integration

Cross-functional teamwork

Validation documentation

Educación

Engineering Degree

Master’s in Science (plus)

Herramientas

URD/URS templates

IQ/OQ/PQ tools

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.

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.

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).