Validation Engineer I – Equipment Validation
Location: Apodaca, Reciente León, Mexico

We are seeking a Validation Engineer I to support equipment qualification and validation activities within the medical device industry. This position will assist with protocol preparation, execution, data collection, and reporting to ensure manufacturing equipment is installed correctly, operates as intended, and consistently meets established requirements.This is a junior engineering role working under the guidance of experienced validation engineers and project leaders.

KEY RESPONSIBILITIES:

- Support the preparation, execution, and documentation of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for manufacturing equipment.
- Verify equipment installation, utilities, calibration status, operating parameters, and required documentation against approved specifications.
- Execute equipment testing according to approved protocols, recording results accurately and collecting supporting evidence.
- Assist with pre-validation trials, equipment readiness assessments, and basic troubleshooting alongside Engineering, Manufacturing, Maintenance, and Quality.
- Identify and document deviations or unexpected results and support investigations and corrective actions under supervision.
- Compile validation data and assist with preparing completion reports and supporting documentation.
- Follow Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), safety procedures, and applicable quality system requirements.
- Support change control activities and assessments of equipment modifications that may require requalification.




- Participate in meetings conducted in English and support communication with English-speaking visitors during equipment reviews, site visits, and validation activities.

BASIC QUALIFICATIONS:

- Bachelor’s degree in Mechanical, Electrical, Mechatronics, Industrial, Biomedical Engineering, or a related engineering field.
- Approximately 0–2 years of relevant experience in equipment validation, manufacturing engineering, quality, or a related area. Relevant internships or co-op experience will be considered.
- Basic understanding of IQ, OQ, and PQ and their application to equipment used in medical device manufacturing.
- Basic knowledge of GMP, GDP, and controlled technical documentation.
- Ability to read equipment specifications, follow test procedures, and document results clearly and accurately.
- Basic data analysis skills and proficiency with Microsoft Excel and Word.
- Strong attention to detail, organization, teamwork, and willingness to learn.
- Intermediate to upper-intermediate English, sufficient to understand and participate in technical meetings, follow instructions, ask questions, provide status updates, and communicate with English-speaking visitors. Ability to read and complete technical documentation in English is required.

PREFERRED QUALIFICATIONS:

- Internship or professional experience in the medical device industry.
- Exposure to manufacturing equipment qualification, calibration, preventive maintenance, or equipment troubleshooting.
- Familiarity with basic statistical tools, such as Minitab.
- Basic knowledge of medical device quality systems, including ISO 13485.

MXOPS

Job Type: Contract

Pay: $100.00 - $200.00 per month

Work Location: In person

📌 Ingeniero de Validacion I (Dispositivos Médicos) (México)
🏢 Bepc
📍 México