What are the responsibilities and job description for the Validation Engineer I position at BEPC Inc. - Business Excellence Professional Consulting?
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.
Salary : $57 - $62