Senior Validation Engineer

BEPC Inc. - Business Excellence Professional Consulting; Ciudad Juárez; Presencial; MXN 1.080.496 - 1.440.662; A tiempo parcial

Descripción de la vacante

A consulting firm in Ciudad Juárez is seeking a Senior Validation Engineer to provide technical support for validation activities, develop testing protocols, and ensure compliance with Good Manufacturing Practices. The ideal candidate will have a Bachelor’s degree in Engineering and substantial experience in the manufacturing or medical device industries. This contract position requires strong presentation skills, knowledge of Lean methodologies, and experience with Design of Experiments. Join a fast-growing team in a mid-senior level position.

Formación

• 4–6 years of experience in the manufacturing industry or 5–6 years in the medical device industry.
• Strong background in statistics and project management principles.
• Intermediate knowledge of Six Sigma, DMAIC, and Kaizen.

Responsabilidades

• Provide technical engineering support for validation activities.
• Develop and execute validation protocols including IQ, OQ, PQ, and CSV.
• Ensure all validation activities comply with GMP and are completed on time.

Conocimientos

Presentation skills

Design of Experiments (DOE)

Lean methodologies

Six Sigma

Statistics

Educación

Bachelor’s degree in Engineering

Descripción del empleo

Senior Validation Engineer – Ciudad Juárez

BEPC has an open position in the Ciudad Juárez area for a Senior Validation Engineer to join our fast-growing team of consultants.

Key Responsibilities

• Provide technical engineering support for validation activities, including writing and executing Installation Qualification (IQ) protocols, and supplying data for validation completion reports.
• Write and execute Operational Qualification (OQ) protocols and provide supporting data for completion reports.
• Write and execute Performance Qualification (PQ) protocols and provide supporting data for completion reports.
• Develop and execute Computer System Validation (CSV) protocols.
• Develop and execute Total Maintenance Validation (TMV) protocols.
• Write and execute SAT (Site/Factory Acceptance Testing) validation protocols and provide data for completion reports.
• Conduct experiments during the pre-validation phase and perform additional experiments as required.
• Ensure all assigned validation activities are completed on time and in compliance with current requirements and Good Manufacturing Practices (GMP).
• Demonstrate strong knowledge of validation processes, GMP, and Good Documentation Practices (GDP).
• Execute validation activities, including the creation of calibration and preventive maintenance documentation and records.

Required Qualifications

• Bachelor’s degree in Engineering (Master of Science preferred).
• 4–6 years of experience in the manufacturing industry and/or 5–6 years of experience in the medical device industry.
• Strong presentation skills when working with teams and clients.
• Solid experience developing factorial experiments (Design of Experiments – DOE).
• Extensive knowledge of Lean methodologies.
• Intermediate knowledge of Six Sigma, DMAIC, and Kaizen.
• Intermediate knowledge of Project Management principles.
• Strong background in statistics.

Seniority level: Mid-Senior.

Employment type: Contract.

Job function: Engineering and Manufacturing.

Industries: Manufacturing, Medical Equipment Manufacturing, and Business Consulting & Services.