Ingeniero de Vallidación Staff - 30877

BEPC Inc. - Business Excellence Professional Consulting; Ciudad Juárez; On-site; MXN 540,000 - 900,000; Full time

Job summary

BEPC Inc. seeks a Staff Validation Engineer in Mexico to lead end-to-end validation strategies for process, equipment, computer systems and maintenance.

You will drive DOE development, Lean Six Sigma initiatives and project-level execution while collaborating with Operations, Design and Engineering teams to ensure products meet GMP, regulatory and design requirements. Responsibilities include IQ/OQ/PQ/CSV/TMV validation protocols, SAT testing, pre-validation experiments, and maintaining

Qualifications

• Solid skills in developing Factorial Experiments (DOE).
• Strong knowledge in Lean Six Sigma, DMAIC and Kaizen.
• Good presentation skills before groups/clients.

Responsibilities

• Provide validation support, write and execute IQ protocols and contribute data for completion reports.
• Provide validation support, write and execute OQ protocols and contribute data for completion reports.
• Provide validation support, write and execute PQ protocols and contribute data for completion reports.
• Provide validation support for CSV protocols.
• Provide validation support for TMV protocols.
• Provide validation support for SAT validation protocols and contribute data for completion reports.
• Run experiments during the pre-validation phase and as needed.
• Ensure validation activities comply with GMP and documentation practices (GDP).
• Create forms for calibration and preventive maintenance records.
• Support development of production of new products.
• Analyze and help develop manufacturing functions, capabilities and facilities.
• Collaborate with Operations and Design teams to verify and validate regulatory and design requirements.

Skills

Factorial Experiments (DOE)

Lean Six Sigma

Presentation skills

Education

Engineering degree

Job description

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 Validation Engineer 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:

• 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.
• Provide technical engineering support for validations, write, and execute Test Method Validation (TMV) protocols.
• Provide technical engineering support for validations, write, and execute SAT (Factory Acceptance Testing) validation protocols, and provide data to write completion reports for assigned validations.
• 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)
• 7 - 10 years of experience in manufacturing industry and/or 6 – 9 years of experience in medical industry
• Good presentation skills before groups/clients.
• Solid skills in developing Factorial Experiments (DOE).
• Strong knowledge in Lean Six Sigma, DMAIC and Kaizen.