Validation Engineer I (Medical Industry)

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

Job summary

A specialized engineering consulting firm in Santa Clara is seeking a Validation Engineer I. The role involves ensuring compliance and quality control within the medical industry, with responsibilities that include developing qualification protocols and managing validation projects. Ideal candidates will have a Bachelor's degree in Engineering or Science, and at least one year of relevant experience in a regulated environment. Strong analytical skills and collaboration capabilities are essential for success in this position.

Qualifications

• 1 year of validation experience in medical device, pharmaceutical or similar regulated industry.
• Knowledge of ISO 13485, FDA 21 CFR Part 820, Part 11, GMP, and GAMP standards.

Responsibilities

• Develop equipment and fixture matrices for medical device regulations.
• Execute Installation Qualification (IQ) and Operational Qualification (OQ) protocols.
• Manage multiple validation projects simultaneously.

Skills

Quality Control

Risk Management

Technical Documentation

Analytical Skills

Collaboration

Education

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

Job description

Validation Engineer I (Medical Industry)

Base pay range: $60.00/hr – $62.00/hr

BEPC Inc. provides specialized engineering and IT project management services to Fortune 500 companies in the life science and technology industries, including the medical device sector. We have an open position for a Validation Engineer I in the Santa Clara, CA area.

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.

Key Responsibilities:

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

Qualifications:

• 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.
• Knowledge of ISO 13485, FDA 21 CFR Part 820, Part 11, GMP, and GAMP standards related to equipment validation.
• Must be able to speak, comprehend, and write English.

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