Equipment Validation Engineer

Duration: 12 Months Contract

Description

• Develop and implement advanced manufacturing technologies to support new product introductions, site capacity expansion, and transformational initiatives within a regulated medical device manufacturing environment.
• Design manufacturing processes and equipment solutions to ensure manufacturability, scalability, quality, and regulatory compliance from concept through process qualification and commercial release.
• Lead engineering activities and deliverables in support of cross-functional project plans, ensuring alignment with project scope, timelines, and business objectives.
• Author, review, and execute validation lifecycle documentation including User Requirements Specifications (URS), Risk Assessments, Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Develop and maintain manufacturing procedures, work instructions, process specifications, and supporting documentation to ensure standardized and compliant operations.
• Coordinate qualification and commissioning activities for manufacturing equipment, automation systems, utilities, and supporting software applications.
• Interface with internal stakeholders and external suppliers to resolve technical issues, manage project deliverables, support equipment implementation, and drive successful project execution.
• Support change control, deviation investigations, root cause analysis, risk assessments, and continuous improvement initiatives to enhance manufacturing performance and product quality.
• Review technical drawings, equipment designs, and vendor documentation to verify compliance with approved requirements and quality standards.
• Ensure compliance with FDA regulations, ISO standards, GMP requirements, quality system procedures, environmental health and safety requirements, and data integrity principles.