Staff Validation Engineer – Automation & Equipment

Medical Device Industry

POSITION OVERVIEW

BEPC Inc. is seeking a Staff Validation Engineer with extensive medical device manufacturing experience and strong hands-on expertise in automation, PLC-controlled equipment, and troubleshooting.

This role will lead validation strategies for manufacturing processes, automated equipment, computer systems, and test methods used in medical device production. The engineer will collaborate with Quality, Operations, Maintenance, Automation, and Design Engineering to ensure equipment and processes consistently produce devices that meet established quality, regulatory, and design requirements.

KEY RESPONSIBILITIES

- Lead the development, execution, and documentation of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for medical device manufacturing processes and equipment.
- Develop and execute Computer Systems Validation (CSV) and Test Method Validation (TMV) protocols, as applicable.
- Support Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) for new or modified manufacturing equipment.
- Provide hands-on technical support for automated medical device manufacturing equipment, including PLCs, HMIs, sensors, actuators, vision systems, and machine controls.
- Troubleshoot equipment, automation, and control system failures, perform root cause analysis, and coordinate corrective actions with Engineering, Maintenance, Quality, and equipment suppliers.
- Review PLC logic, HMI functionality, equipment sequences, alarms, interlocks, operating parameters, and recipes to support troubleshooting and validation.
- Assess the impact of PLC/HMI programming changes, software updates, equipment modifications, and recipe adjustments on validated processes and product quality.
- Verify equipment functionality, operating ranges, alarms, interlocks, and process controls through documented testing.
- Support installation, commissioning,



qualification, and transfer of equipment used in medical device assembly, inspection, and testing.
- Develop risk-based validation studies that address critical process parameters and product quality attributes.
- Design and execute pre-validation studies and Design of Experiments (DOE) to establish operating windows and demonstrate process capability.
- Prepare validation plans, protocols, completion reports, and supporting documentation in accordance with the client’s quality management system.
- Investigate validation deviations, document their impact, and support resolution before validation approval and equipment release.
- Establish calibration and preventive maintenance requirements and associated records for validated equipment.
- Support change control activities and determine requalification or revalidation requirements.
- Apply statistical analysis and Lean Six Sigma methodologies, including DMAIC and Kaizen, to improve equipment reliability, process capability, and product quality.
- Support new product introduction and manufacturing transfers while ensuring alignment with product specifications and design requirements.
- Lead validation projects and communicate schedules, technical risks, and results to cross-functional teams and clients.
- Ensure validation activities comply with Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), applicable medical device requirements, and internal procedures.

BASIC QUALIFICATIONS

- Bachelor’s degree in Electrical, Mechanical, Mechatronics, Automation, Manufacturing, Biomedical Engineering,



or a related engineering discipline. A master’s degree is a plus.
- 6–9 years of relevant experience in the medical device industry, with substantial responsibility for equipment and process validation.
- Demonstrated hands-on experience with industrial automation, PLC-controlled manufacturing equipment, and equipment troubleshooting is required.
- Experience reviewing and troubleshooting PLC logic and HMI functionality using platforms such as Allen-Bradley/Rockwell Automation or Siemens.
- Strong understanding of electrical diagrams, control sequences, sensors, actuators, pneumatic systems, and automated equipment operation.
- Extensive experience developing, executing, and documenting IQ/OQ/PQ protocols in medical device manufacturing.
- Experience supporting CSV, TMV, FAT, and SAT activities.
- Strong understanding of medical device quality systems, including ISO 13485, change control, risk management, and validation documentation.
- Ability to assess how equipment failures, process changes, and automation modifications may affect device quality and validated status.
- Strong skills in DOE, factorial experiments, statistical analysis, and process capability evaluation.
- Strong knowledge of Lean Six Sigma, DMAIC, and Kaizen.
- Strong project management, technical writing, root cause analysis, and presentation skills.

PREFERRED QUALIFICATIONS

- Experience programming or modifying PLC/HMI applications.
- Experience with vision inspection systems, robotics, servo drives, and industrial communication networks.
- Experience validating automated assembly, inspection, or testing equipment for medical devices.
- Experience supporting medical device manufacturing transfers, new product introductions, and equipment suppliers.
- Experience using Minitab or comparable statistical analysis software.

MXOPS

Job Type: Contract

Pay: $100.00 - $200.00 per month

Work Location: In person

📌 Ingeniero de Validación Staff - 30555 (México)
🏢 Bepc
📍 México