Automation & Validation Engineer — Medical Devices (Onsite, TX)

BEPC Inc. - Business Excellence Professional Consulting; San Angelo (TX); On-site; USD 55,000 - 62,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Onsite role

Job summary

BEPC Inc. is seeking an Automation and Validation Engineer to join our client’s site in San Angelo, TX.

This W2 contract role supports the development, implementation, and maintenance of automated systems while ensuring validation processes comply with FDA/ISO requirements. The engineer will collaborate with cross‑functional teams to test medical devices, lead IQ/OQ/PQ validations, perform risk assessments, and document results to meet regulatory standards.

Qualifications

• Bachelor’s degree in Engineering, Electrical, or related field.
• 4+ years in automation and validation, medical device or regulated industry.
• Knowledge of FDA 21 CFR Part 820 and ISO 13485.
• Experience with IQ/OQ/PQ and risk assessment (FMEA).
• Strong problem-solving and documentation skills.

Responsibilities

• Develop, validate, and maintain automated systems for medical device production and testing.
• Lead validation activities (Software, Hardware, Process) per FDA/ISO.
• Create IQ/OQ/PQ validation protocols for manufacturing and labs.
• Author validation reports post IQ/OQ/PQ completion.
• Perform risk assessments and propose corrective actions.
• Collaborate with engineering, quality, and regulatory teams.
• Document validation processes and results per regulatory standards.
• Support new product development and process improvements via automation.

Skills

Automation verification

Validation methods

Documentation practices

Regulatory knowledge

Education

Bachelor's degree in Engineering, Electrical, or a related field

Tools

Automation tools & systems

Job description

BEPC Inc. is seeking an Automation and Validation Engineer to join our client’s site in San Angelo, TX.

This W2 contract role supports the development, implementation, and maintenance of automated systems while ensuring validation processes comply with FDA/ISO requirements. The engineer will collaborate with cross‑functional teams to test medical devices, lead IQ/OQ/PQ validations, perform risk assessments, and document results to meet regulatory standards.