About this opportunity
BEPC Inc. - Business Excellence Professional Consulting lists this Validation Engineer I opportunity in san jose, California. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Validation Engineer I
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.
Seniority level
Associate
Employment type
Contract
Job function
Medical Equipment Manufacturing
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Worksite address
san jose, CA, 95199, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.