Validation Engineer – IQ/OQ/PQ, cGMP Compliance

Katalyst-Healthcares-; Jersey City (NJ); On-site; USD 90,000 - 150,000; Full time

Job summary

Katalyst-Healthcare is seeking a Validation Engineer to support GMP validation activities and equipment qualification in a pharmaceutical environment in New Jersey. You will develop IQ/OQ/PQ protocols and ensure cGMP compliance.

Collaborate with QA, Engineering and Manufacturing, prepare reports, and assist deviation investigations while upholding data integrity and GDP principles. Prior experience with cell therapy equipment qualification is a plus.

Qualifications

• Bachelor's degree in engineering, life sciences, or related field.
• Minimum 5+ years of cGMP experience in pharma/biotech.
• Hands-on IQ/OQ/PQ validation activities experience.

Responsibilities

• Support IQ, OQ, and PQ for equipment qualifications.
• Develop, execute, and review validation protocols and scripts.
• Prepare validation summary reports and maintain docs.
• Support deviation investigations and CAPA.
• Ensure compliance with cGMP, GAMP, 21 CFR Part 11, GDP.
• Review validation records for accuracy and traceability.
• Collaborate with QA, Engineering, Manufacturing, and others.
• Support qualification of cell therapy equipment when applicable.
• Maintain validation docs and readiness for audits.

Skills

cGMP experience

Regulatory compliance

CAPA investigations

Data integrity principles

Cross-functional collaboration

Education

Bachelor's degree in engineering, life sciences, biotechnology, chemistry, or related field

Tools

IQ/OQ/PQ protocols

Job description

Katalyst-Healthcare is seeking a Validation Engineer to support GMP validation activities and equipment qualification in a pharmaceutical environment in New Jersey. You will develop IQ/OQ/PQ protocols and ensure cGMP compliance.

Collaborate with QA, Engineering and Manufacturing, prepare reports, and assist deviation investigations while upholding data integrity and GDP principles. Prior experience with cell therapy equipment qualification is a plus.