Automation & Validation Engineer

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

Job summary

BEPC Inc. is actively seeking an Automation and Validation Engineer to join our client’s site in San Angelo, TX. This role focuses on developing, implementing, and maintaining automated systems for medical device production, ensuring validation processes meet FDA, ISO, and industry standards.

The successful candidate will lead IQ/OQ/PQ activities, create robust validation protocols, and document outcomes. Collaboration with cross-functional teams and strong attention to regulatory requirements

Qualifications

• Bachelor's degree in Engineering or related field.
• Minimum 4 years in automation and validation engineering in medical device or regulated industry.
• Knowledge of FDA 21 CFR Part 820 and ISO 13485.

Responsibilities

• Develop, validate, and maintain automated systems for medical device production and testing.
• Lead validation activities (IQ/OQ/PQ) for medical devices per regulatory requirements.
• Create IQ/OQ/PQ validation protocols and validation completion reports.
• Design, implement, and maintain automated test scripts for validation.
• Perform risk assessments and implement corrective actions to improve reliability of automation systems.
• Collaborate with engineering, quality, and regulatory teams to ensure compliance.
• Document validation processes, results, and reports per regulatory standards.

Skills

Automation engineering

Validation testing

IQ/OQ/PQ

Regulatory compliance

FDA 21 CFR Part 820

ISO 13485

Documentation

Cross-functional collaboration

Education

Bachelor's degree in Engineering

Tools

Automation tools

Medical device testing

Job description

BEPC is actively looking for Automation and Validation Engineer, in San Angelo, TX area!

W2 Contract – 1 year with possible extensions!

Benefits include medical, dental, vision, and life insurance

Pay Rate: $40.00 - $45.00/hour - Determined based on experience (Paid Weekly)

Work Model: Onsite role

Note: This is a W2 only role — C2C, C2H will not be considered

Summary of the Role:

BEPC is seeking a highly motivated Automation and Validation Engineer to join our client’s site in San Angelo, TX. This role will support the development, implementation, and maintenance of automated systems while ensuring validation processes comply with industry standards and regulatory requirements.

The Automation and Validation Engineer will collaborate with cross-functional teams to support the development and testing of medical devices and ensure safety, quality, and performance criteria are met.

Summary of Duties and Responsibilities:

• Develop, validate, and maintain automated systems for medical device production and testing.
• Lead and execute validation activities, including Software, Hardware, and Process Validation, for medical devices in compliance with FDA, ISO, and other regulatory requirements.
• Generate equipment and fixture matrices for MVP, with qualification requirements defined by the medical device company.
• Create detailed and specific IQ/OQ validation protocols for medical device manufacturing and laboratory settings in accordance with requirements and standards.
• Author validation completion reports following successful completion of IQ/OQ validations.
• Execute detailed and technical PQ validations in accordance with requirements and standards.
• Author validation completion reports following successful completion of PQ validations.
• Design, implement, and maintain automated test scripts, ensuring all validation protocols are met.
• Perform risk assessments and provide corrective actions to improve the reliability of automated systems.
• Collaborate with engineering, quality, and regulatory teams to ensure automation and validation activities meet industry standards.
• Document validation processes, results, and reports in compliance with applicable regulatory standards.
• Support new product development and process improvement efforts through automation and validation strategies.
• Troubleshoot and resolve issues related to automated systems and ensure the reliability of validation equipment.
• Maintain up-to-date knowledge of industry regulations and best practices in automation and validation within medical device development.

Main Qualifications:

• Education: Bachelor’s degree in Engineering, Electrical, or a related field.
• Experience: Minimum of 4 years of experience in automation and validation engineering, specifically within the medical device or regulated industry.
• Strong knowledge of regulatory requirements, including FDA 21 CFR Part 820 and ISO 13485.
• Experience with automation tools and systems.
• Familiarity with risk management processes, including FMEA, and statistical analysis.
• Solid understanding of test methodologies and validation protocols, including IQ, OQ, and PQ.
• Excellent problem-solving, troubleshooting, and analytical skills.
• Strong attention to detail and excellent documentation practices.
• Effective communication and interpersonal skills with the ability to work collaboratively with cross-functional teams.

Preferred qualifications:

• Master’s degree in Engineering, Electrical, or a related field.

About BEPC

BEPC Inc., founded in 2007, is a 100% employee-owned company providing top-tier consulting and staffing solutions across industries like technology, engineering, manufacturing, and project management. At BEPC, we are driven by innovation and a commitment to excellence. We take pride in fostering a collaborative and innovative environment where our team members thrive. With competitive benefits, including medical, dental, vision, and life insurance, BEPC is dedicated to supporting our employees' personal and professional growth.