Validation Engineer I
$57 - $62 per hourBEPC Inc. - Business Excellence Professional Consulting
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 #J-18808-Ljbffr BEPC Inc. - Business Excellence Professional ConsultingVacancy posted 3 days ago
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