GMP Validation Lead for Cell Therapy Equipment

ADP, Inc.; Princeton (NJ); On-site; USD 110,000 - 140,000; Full time

Job summary

Made Scientific in Princeton, NJ, is seeking a Validation Engineer to manage and implement equipment and facility validation programs, ensuring compliance with regulatory requirements and industry best practices.

The role supports GMP manufacturing, leads IQ/OQ/PQ activities, CSV, change controls, and CAPA management in an ISPE-aligned framework, partnering with Manufacturing, Quality Assurance, and Engineering.

Qualifications

• Bachelor's degree in a technical or scientific discipline required; Master's degree preferred.
• Minimum of 5 years of experience in a Validation or related role.
• Travel within (50 miles)
• Experience working in a cGMP-regulated environment strongly preferred.
• Experience in cell and gene therapy manufacturing preferred.
• Working knowledge of CFR requirements and validation-related cGMP standards.
• Experience leading validation projects or working with cross-functional teams.
• Experience authoring and reviewing technical documentation.
• Ability to perform physical job requirements including standing, walking, and lifting up to 15 pounds.

Responsibilities

• Design, develop, and lead Equipment and Facility Validation initiatives.
• Ensure the Validation Master Plan remains current and aligned with regulatory and operational requirements.
• Prepare and execute IQ/OQ/PQ protocols for equipment, instruments, facilities, and utilities, and associated software, in compliance with cGMP standards.
• Conduct Computer System Validation (CSV) activities in accordance with FDA regulations and industry standards (e.g., GAMP 5).
• Collaborate cross-functionally with Manufacturing, Quality Assurance, and Engineering teams to support validation efforts.
• Ensure timely and successful completion of validation projects, including risk assessments and impact analyses for new systems or changes.
• Identify and resolve non-conformances or deviations encountered during IQ/OQ/PQ execution and implement appropriate mitigation strategies.
• Generate qualification reports and summarize validation results for review and approval.
• Perform requalification of equipment, facilities, and utilities in accordance with change control requirements.
• Initiate and manage quality records such as change controls, deviations, and CAPAs within the eQMS system.
• Promote a culture of continuous improvement across Manufacturing, Engineering, and Quality environments.
• Develop and maintain validation procedures in accordance with corporate guidelines, cGMP requirements, and ISPE standards.
• Review change controls, SOPs, calibration records, and maintenance documentation to ensure systems remain in a validated state.
• Provide oversight of GMP operations to ensure timely identification, documentation, and escalation of deviations, non-conformances, and compliance concerns, with appropriate risk mitigation actions.
• Perform other duties as assigned.

Education

Bachelor's degree in Engineering, Facilities Management, or related field

Master's degree preferred

Tools

eQMS

Job description

Made Scientific in Princeton, NJ, is seeking a Validation Engineer to manage and implement equipment and facility validation programs, ensuring compliance with regulatory requirements and industry best practices.

The role supports GMP manufacturing, leads IQ/OQ/PQ activities, CSV, change controls, and CAPA management in an ISPE-aligned framework, partnering with Manufacturing, Quality Assurance, and Engineering.