Validation Engineer Senior

Overview

Senior Validation Engineer onsite who leads development, characterization, optimization, and validation of automated and semi-automated combination product assembly and packaging processes in GMP manufacturing. Applies advanced engineering principles to ensure robust, compliant, and efficient manufacturing for commercial production and new product introductions. Provides day-to-day technical support for commercial manufacturing, including equipment and process troubleshooting, critical parameter assessment and optimization, process performance monitoring, deviation investigations, root cause analysis, and continuous improvement to enhance product quality, process capability, and operational excellence.

Oversees preparation and approval of technical documentation and supports lifecycle management and technology transfer activities.

• Provide technical support for commercial manufacturing through equipment and process troubleshooting, critical parameter optimization, deviation investigations, and continuous improvement initiatives.
• Author, execute, and approve engineering studies and CQV protocols and reports for manufacturing equipment, computerized systems, and processes.
• Develop and maintain characterization tests, commissioning, qualification, and validation (CQV) documentation, including validation plans, master plans, and summary reports.
• Prepare technical reports supporting equipment lifecycle management, process improvements, technology transfers, and new product introductions (NPI).
• Collaborate cross-functionally with Manufacturing, Quality, Validation, Engineering, and other technical teams; lead complex engineering initiatives; resolve technical challenges; and identify opportunities to improve equipment reliability, process performance, and manufacturing capability.
• Serve as a Subject Matter Expert (SME) for combination products, device assembly technologies, and GMP manufacturing processes, ensuring regulatory compliance and successful commercialization and lifecycle management of the product portfolio.

• Doctorate degree OR Masters degree with 2 years of experience OR Bachelors degree with 4 years of experience OR Associates degree with 8 years of experience OR High school diploma / GED with 10 years of experience.

Pay range is $54 - $59 per hour with full benefits available, including paid time off, medical/dental/vision/life insurance, 401K, parental leave, and more. Compensation reflects cost of labor across several US geographic markets and may vary based on location, knowledge, skills, and experience.