Validation Engineer I

BEPC has an open position for a Validation Engineer I

Location: Santa Clara, CA

Benefits: Medical, Dental, Vision, and Life Insurance

Pay Rate: $57-$62 per hour (Paid Weekly)

Term: 6-months contract with possible extensions

Requirements: Bachelor’s degree in engineering, Science, or a related technical field, 1 year of validation experience within a medical device, pharmaceutical, biotechnology, or other regulated industry.

**NO CORP-TO-CORP CANDIDATES WILL BE CONSIDERED**

**BEPC does not accept C2C, C2H, or W2 referral applications. **

Duties & Responsibilities

• Develop equipment and fixture matrices with defined qualification requirements in accordance with medical device regulations and client standards.
• Create detailed, 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 successful protocol execution.
• 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 implement corrective actions to resolve validation and compliance issues.
• Ensure validation activities comply with FDA regulations, ISO 13485, GMP, GAMP, and internal policies.
• Manage multiple validation projects simultaneously, including documentation, scheduling, and communication with internal and client stakeholders.
• Own and execute the full equipment/fixture validation lifecycle, from documentation development through testing and final reporting.

Education & Experience Requirements

• Bachelor’s degree in engineering, Science, or a related technical field.
• 1 year of validation experience within a medical device, pharmaceutical, biotechnology, or other regulated industry.
• Working knowledge of:
• ISO 13485
• FDA 21 CFR Part 820
• 21 CFR Part 11
• GMP
• GAMP
• Must be able to speak, read, comprehend, and write English.