Validation Engineer I - Medical Devices (IQ/OQ, GMP)

BEPC Inc. - Business Excellence Professional Consulting; Santa Clara (CA); On-site; USD 82,656 - 85,411; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

Job summary

A consulting and staffing solutions company is seeking a Validation Engineer I in Santa Clara, CA. This role requires at least 1 year of validation experience in a medical device or pharmaceutical industry. Responsibilities include developing qualification matrices, preparing and executing IQ/OQ protocols, and ensuring compliance with FDA regulations. The position offers a contract term of 6 months with possible extensions and is backed by competitive benefits including medical, dental, vision, and life insurance.

Qualifications

• 1+ years of experience as a Validation Engineer in a regulated industry.
• Knowledge of FDA and MDD GMP requirements related to medical devices.
• Experience with equipment validation standards.

Responsibilities

• Develop equipment and fixture matrices in compliance with regulations.
• Prepare and execute IQ/OQ protocols for equipment.
• Write validation summary reports after protocol execution.
• Perform troubleshooting and corrective actions for compliance issues.
• Manage multiple validation projects and communications with stakeholders.

Skills

ISO 13485

Validation experience

English proficiency

FDA regulations knowledge

Education

Bachelor’s degree in Engineering, Science, or related field

Job description

A consulting and staffing solutions company is seeking a Validation Engineer I in Santa Clara, CA. This role requires at least 1 year of validation experience in a medical device or pharmaceutical industry. Responsibilities include developing qualification matrices, preparing and executing IQ/OQ protocols, and ensuring compliance with FDA regulations. The position offers a contract term of 6 months with possible extensions and is backed by competitive benefits including medical, dental, vision, and life insurance.