Cell Therapy Validation Engineer — GMP/CSV Expert

Made Scientific; Princeton (NJ); On-site; USD 110,000 - 160,000; Full time

Job summary

Made Scientific, a US-based cell therapy CDMO, is seeking a Validation Engineer to manage and advance Equipment and Facility Validation programs, ensuring compliance with cGMP and regulatory standards. The role supports GMP operations and maintains validated state for equipment, systems, and facilities.

The candidate will lead IQ/OQ/PQ execution, perform CSV activities per FDA and GAMP 5 guidelines, and collaborate with Manufacturing, Quality Assurance, and Engineering to drive risk assessments,

Responsibilities

• Design and lead Equipment and Facility Validation initiatives.
• Prepare IQ/OQ/PQ protocols for equipment, facilities, utilities, and software.
• Execute CSV activities in line with FDA and GAMP 5 standards.
• Collaborate with Manufacturing, QA, and Engineering to support validation.
• Manage risk assessments and impact analyses for new systems or changes.
• Generate qualification reports and summarize validation results.
• Perform requalification and maintain validated state per change control.
• Initiate and manage quality records within the eQMS system.
• Drive continuous improvement across Manufacturing, Engineering and Quality.

Job description

Made Scientific, a US-based cell therapy CDMO, is seeking a Validation Engineer to manage and advance Equipment and Facility Validation programs, ensuring compliance with cGMP and regulatory standards. The role supports GMP operations and maintains validated state for equipment, systems, and facilities.

The candidate will lead IQ/OQ/PQ execution, perform CSV activities per FDA and GAMP 5 guidelines, and collaborate with Manufacturing, Quality Assurance, and Engineering to drive risk assessments,