On-Site Cell Therapy Validation Engineer - GMP

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

Job summary

Made Scientific, a US-based cell therapy CDMO, seeks a Validation Engineer to manage and implement equipment and facility validation programs for GMP operations. The role requires leading IQ/OQ/PQ activities, CSV, and change control processes on-site in a regulated environment.

The ideal candidate has 5+ years in validation, CFR/cGMP familiarity, and experience with cell/gene therapy manufacturing. Join a team focused on quality, compliance, and continuous improvement at our East Norriton

Qualifications

• Bachelor’s degree in a technical or scientific discipline is required; Master’s degree preferred.
• Minimum 5 years of experience in a Validation or related role.
• Experience 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 cross-functional teams.
• Experience authoring and reviewing technical documentation.
• Must be able to perform physical job requirements (standing, lifting up to 15 lbs).

Responsibilities

• Design, develop, and lead Equipment and Facility Validation initiatives.
• Maintain the Validation Master Plan in line with regulatory requirements.
• Prepare IQ/OQ/PQ protocols for equipment, facilities, and utilities.
• Conduct CSV activities per FDA regulations and GAMP 5 guidelines.
• Collaborate cross-functionally with Manufacturing, QA, and Engineering.
• Ensure timely completion of validation projects and risk assessments.
• Identify deviations and implement mitigation strategies during IQ/OQ/PQ.
• Generate qualification reports and oversee requalification and change controls.

Skills

Validation experience

cGMP knowledge

Cross-functional leadership

Technical documentation

CSV / GAMP 5

Education

Bachelor’s degree in technical or scientific field

Master’s degree preferred

Tools

eQMS systems

GAMP 5

Job description

Made Scientific, a US-based cell therapy CDMO, seeks a Validation Engineer to manage and implement equipment and facility validation programs for GMP operations. The role requires leading IQ/OQ/PQ activities, CSV, and change control processes on-site in a regulated environment.

The ideal candidate has 5+ years in validation, CFR/cGMP familiarity, and experience with cell/gene therapy manufacturing. Join a team focused on quality, compliance, and continuous improvement at our East Norriton