Validation Engineer – Medical Device Industry

BEPC Inc. provides engineering solutions and project management services to Fortune 500 companies in the life sciences and technology industries. We are seeking a Validation Engineer with medical device manufacturing experience and hands-on knowledge of IQ, OQ, and PQ validation protocols.

Important: Candidates must have previous professional experience in the medical device industry.

Key Responsibilities

- Provide technical engineering support for equipment, process, and manufacturing validations.
- Write and/or support Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
- Execute validation protocols, document results, analyze data, and provide information for validation completion reports.
- Ensure assigned validation activities are completed on time and in accordance with internal procedures, regulatory requirements, and Good Manufacturing Practices (GMP).
- Prepare validation documentation in compliance with Good Documentation Practices (GDP).
- Support the creation and maintenance of calibration and preventive maintenance records.
- Identify and document deviations encountered during validation activities.
- Collaborate with Engineering, Quality, Manufacturing, Maintenance, and other cross-functional teams.
- Maintain accurate, complete, and audit-ready validation records.

Required Qualifications





- Bachelor’s degree in Engineering or a related technical field.
- Professional experience in the medical device industry is mandatory.
- Experience supporting or executing validation protocols, including IQ, OQ, and PQ.
- Knowledge of fundamental validation principles and practices.
- Knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
- Ability to interpret technical information, document validation results, and support completion reports.
- Strong attention to detail, organization, and technical documentation skills.

Preferred Qualifications

- Experience using Windchill or a similar document-control system.
- Intermediate to advanced English proficiency.
- Experience preparing validation protocols and completion reports.
- Knowledge of calibration and preventive maintenance documentation.
- Experience working in a regulated manufacturing environment.

Skills

- IQ, OQ, and PQ validation
- Validation protocol execution
- Technical documentation
- GMP and GDP compliance
- Data collection and analysis
- Calibration and preventive maintenance records
- Cross-functional collaboration
- Problem-solving and attention to detail

Important: Candidates must have previous professional experience in the medical device industry.

MXOPS

Job Type: Full-time

Pay: $100.00 - $200.00 per month

Work Location: In person

📌 Validation Engineer (Medical Devices) (México)
🏢 Bepc
📍 México