Validation Engineer

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

Summary

The Validation Engineer will support GMP validation activities and equipment qualification in a pharmaceutical or life sciences environment. The role involves developing and executing Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols, reviewing validation documentation, preparing reports, and supporting deviation investigations. The engineer will ensure compliance with cGMP, GAMP, 21 CFR Part 11, Good Documentation Practices (GDP), and data integrity requirements.

Roles and Responsibilities

• Support equipment qualification and GMP validation activities, including IQ, OQ, and PQ.
• Develop, execute, and review validation protocols, test scripts, and qualification documents.
• Prepare validation summary reports and maintain accurate documentation in accordance with cGMP requirements.
• Support validation deviation investigations, root cause analysis, and corrective and preventive actions (CAPA).
• Ensure compliance with GAMP guidelines, 21 CFR Part 11, GDP, and data integrity standards.
• Review validation records for completeness, accuracy, traceability, and regulatory compliance.
• Collaborate with Quality Assurance, Engineering, Manufacturing, and other cross-functional teams.
• Support qualification of cell therapy manufacturing equipment, where applicable.
• Maintain validation documentation and ensure readiness for internal and external audits.

Education & Experience

• Required: Bachelor's degree in engineering, Life Sciences, Biotechnology, Chemistry, or a related scientific discipline.
• Preferred: Relevant coursework or training in pharmaceutical validation, equipment qualification, GMP, or quality systems.
• Minimum of 5+ year of cGMP experience in the pharmaceutical, biotechnology, or life sciences industry.
• Hands-on experience supporting equipment qualification and validation activities, including IQ/OQ/PQ.
• Experience preparing, executing, and reviewing validation protocols and reports.
• Knowledge of cGMP, GAMP, 21 CFR Part 11, GDP, and data integrity principles.
• Experience supporting validation deviations and investigation documentation.
• Preferred: Cell therapy manufacturing equipment qualification experience.