Validation Technician – Medical Device Industry
BEPC Inc. is seeking a qualified Validation Technician to support validation activities within a regulated medical device manufacturing environment. This position will focus on the execution, documentation, and follow-up of validation protocols for manufacturing equipment, processes, and production lines.
Key Responsibilities
- Execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
- Collect, organize, and accurately document validation data and test results.
- Support engineers during equipment, process, and manufacturing-line validations.
- Verify that equipment and processes meet established acceptance criteria.
- Report protocol deviations, equipment issues, and unexpected results.
- Assist with validation testing, inspections, measurements, and sample collection.
- Maintain complete and accurate validation records according to Good Documentation Practices.
- Support equipment installations, process changes, product transfers, and new product introductions.
- Collaborate with Validation, Manufacturing, Quality, and Engineering teams.
- Follow applicable safety procedures, quality-system requirements, and medical device regulations.
Mandatory Requirements
- Technical degree or completed coursework in Engineering, Electromechanics, Electronics, Manufacturing, Industrial Technology, or a related field.
- Professional experience in the medical device industry is mandatory.
- Hands-on experience executing or supporting IQ, OQ, and PQ protocols.
- Experience completing technical forms, protocols, test records, or controlled documentation.
- Knowledge of manufacturing equipment and production processes.
- Strong attention to detail and ability to follow written procedures.
- Availability to perform validation activities directly on the manufacturing floor.
- English proficiency sufficient to understand and complete technical documentation.
Preferred Qualifications
- Experience with equipment, process, or manufacturing validation.
- Knowledge of GMP and Good Documentation Practices.
- Familiarity with measuring instruments, equipment calibration, and preventive maintenance.
- Experience with document-control or quality-management systems such as Windchill.
- Experience supporting deviations, CAPA, change control, product transfers, or new product introductions.
MXOPS
Job Type: Full-time
Pay: $100.00 - $200.00 per month
Work Location: In person
📌 Validation Technician (Medical Devices Industry) (México)
🏢 Bepc
📍 México