Validation Engineer

We are seeking a Junior to Mid-Level Validation Engineer for a W2 contract role supporting a large-scale GMP manufacturing floor cybersecurity project involving 400+ devices. This position will focus on validation execution, GMP change control, and IOQ testing related to system and infrastructure changes in a regulated environment.

The role also supports SDLC-related documentation, including Quality Assurance Plans (QAPs), and requires basic project coordination skills to support execution during planned manufacturing shutdowns. Senior validation and quality resources will provide oversight on more complex activities.

• →Execute validation activities under GMP change control
• →Author and/or execute IOQ protocols and document test results
• →Support SDLC-driven validation documentation, including QAPs
• →Assist with planning and execution across multiple devices and systems
• →Track validation deliverables, testing readiness, and action items
• →Support audits, inspections, and documentation reviews as needed
• →Collaborate with Quality, Automation, IT/OT, and Engineering teams

• Bachelor’s degree in Engineering, Science, or related field (or equivalent experience)
• 1–5+ years of validation or qualification experience in a GMP/GxP environment
• Hands-on experience executing validation protocols (IQ/OQ/IOQ or CSV-related testing)
• Working knowledge of GMP documentation and change control processes
• Strong organizational and technical writing skills

• Experience validating computerized systems or OT/infrastructure
• Familiarity with SDLC-controlled environments and quality documentation
• Exposure to 21 CFR Part 11, data integrity, or cybersecurity-related initiatives
• Experience supporting validation work during manufacturing shutdowns
• Light project coordination or PM experience

This W2 contract supports a multi-phase project aligned with site shutdowns, beginning in June, continuing through December, and concluding with a final phase in June 2027.