Validation Engineer I (Medical Industry)

Description

• Ensure all validation activities comply with FDA regulations, ISO 13485, GMP, and internal policies.
• Develop equipment and fixture matrices with defined qualification requirements in accordance with medical device regulations and client standards.
• Perform troubleshooting, root cause analysis, and corrective implementation to resolve validation and compliance issues.
• Own and execute the full validation lifecycle for equipment and fixtures, from documentation development through testing and final reporting.
• Manage multiple validation projects simultaneously, including documentation, scheduling, and communication with internal and client stakeholders.
• Execute IQ/OQ protocols, ensuring accurate data collection, documentation integrity, and adherence to regulatory and client requirements.
• Provide technical support for the development and implementation of Standard Operating Procedures (SOPs) related to newly qualified equipment and fixtures.
• Write and issue validation summary reports following the successful execution of IQ/OQ protocols.

Requirements

• -This role is not offered on a C2C basis, and candidates under this arrangement will not be considered--

BEPC has a Santa Clara, CA., area OPEN POSITION for Validation Engineer I to ensure that products, manufacturing equipment, fixtures, and laboratory systems comply with medical device regulations and industry standards. This role requires strong knowledge of quality control and risk management principles, the ability to interpret regulatory guidelines, and strong technical documentation skills. The ideal candidate is detail oriented, analytical, and capable of collaborating with cross-functional teams to ensure safety, reliability, and compliance within a regulated environment.

• Must be able to speak, comprehend, and write English.
• Detailed and Compliant Installation Qualification (IQ) and Operational Qualification (OQ) protocols for manufacturing and laboratory equipment.
• Knowledge of ISO 13485, FDA 21 CFR Part 820, Part 11, GMP, and GAMP standards related to equipment validation.
• Bachelor’s degree in Engineering, Science, or a related technical field.
• 1 year of validation experience within a medical device, pharmaceutical, biotechnology, or similar regulated industry.

Benefits

Training + Development

Interview process

Visa Sponsorship

Security clearance