Validation Engineer I

Description

• Develop equipment and fixture matrices with defined qualification requirements in accordance with medical device regulations and client standards.
• Own and execute the full equipment/fixture validation lifecycle, from documentation development through testing and final reporting.
• Manage multiple validation projects simultaneously, including documentation, scheduling, and communication with internal and client stakeholders.
• Ensure validation activities comply with FDA regulations, ISO 13485, GMP, GAMP, and internal policies.
• 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.
• 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.
• Write and issue validation summary reports following successful protocol execution.

Requirements

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

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.

BEPC has an open position for a Validation Engineer I

• ISO 13485
• FDA 21 CFR Part 820
• Must be able to speak, read, comprehend, and write English.
• 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:

Benefits

Benefits: Medical, Dental, Vision, and Life Insurance

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

Training + Development

Interview process

Visa Sponsorship

Security clearance