Senior Validation Engineer

We are seeking a Senior Validation Engineer to ensure equipment, utilities, and processes remain compliant by creating, reviewing, and executing all necessary validation documentation.

This is a 12 month hourly rate contract position.

Key Responsibilities:

• Author and approve validation protocols, reports, rationales, and risk assessments (IQ/OQ/PQ) ensuring compliance with FDA, ISO, and ICH standards.
• Manage deviations, root cause investigations, and CAPAs; review change controls to ensure validated states are maintained.
• Lead validation activities for facility utilities, manufacturing equipment, and Computer System Validation (CSV).
• Oversee 3rd-party service contracts for utility systems and collaborate with vendors during system start-ups and testing.
• Schedule and perform periodic re-qualifications and represent validation data during management and quality forums.

Requirements:

• Bachelor's Degree in Engineering or a related Science discipline.
• 5+ years of hands-on experience in validation within a regulated environment (Process, Steam Sterilization, Utilities, and CSV).
• Strong understanding of ASTM, ISPE, and current regulatory guidelines; strong IT competency and technical writing skills.
• Proven ability to lead cross-functional teams, manage external contractors, and communicate effectively with stakeholders at all levels.