Validation Engineer

Hiring:

Validation Engineer III Location:

San Diego, CA Duration:

6

Months Contract Type:

W2

Contract Industry:

Medical Devices / Diagnostics This role focuses on leading validation activities that support the Quality Management System within a regulated medical device environment. The ideal candidate will have strong experience in equipment qualification, process validation, technical documentation, and ensuring compliance with FDA and ISO standards. Looking for hands-on engineers with experience in: Equipment Qualification (IQ/OQ/PQ) and Process Validation

FAT/SAT/IQ/OQ/PQ/PV

Protocol Execution Facility and Laboratory Qualification Activities Technical Writing (Protocols, Reports, CAPAs, Deviations, SOPs) Computer System Validation (CSV) and Spreadsheet Validation Thermal Mapping of Temperature-Controlled Equipment and Areas Risk Assessments, Gap Analysis, and Validation Strategy Development Good Documentation Practices (GDP) and cGMP Compliance

FDA 21 CFR

Part 11, 21 CFR 820, ISO 13485, and

ISO 14971

Requirements Root Cause Analysis, 5

Whys, and Investigation Activities Preferred Background:

Bachelor's degree in Engineering, Biology, Chemistry, or a related scientific field 2+ years of validation experience in the Medical Device industry Experience with In Vitro Diagnostic (IVD) equipment such as Real-Time PCR Systems, Freezers, Refrigerators, Environmental Chambers, and Incubators Experience supporting FDA and

ISO 13485

inspections and audits Familiarity with GAMP5 and FDA Computer Software Assurance (CSA) initiatives Experience with Agile, Maximo, and ViewLinc systems Lean Six Sigma or statistical background is a plus

Pay:

$34.00 - $37.00 per hour

Work Location:

In person