Validation Engineer - cGMP, CSV, Equipment & Facilities

Weltraw Consulting Group; Princeton (NJ); On-site; USD 90,000 - 130,000; Full time

Job summary

Weltraw Consulting Group in New Jersey seeks a senior Validation Engineer to manage, develop, and implement Equipment and Facility Validation programs to ensure GMP compliance and regulatory readiness. You will lead IQ/OQ/PQ protocols, perform CSV activities, review change controls, and partner with Manufacturing, QA, and Engineering to sustain a validated state across facilities and utilities.

Travel within 50 miles is required; a Bachelor's in Engineering or related field is necessary, with 5+

Qualifications

• Bachelor’s degree in engineering or related field.
• Minimum 5 years in validation or related role.
• Experience in cGMP, CSV, and regulatory standards.
• Willingness to travel within 50 miles.

Responsibilities

• Lead equipment and facilities validation initiatives.
• Prepare IQ/OQ/PQ protocols for systems and utilities.
• Perform CSV activities per FDA and GAMP 5.
• Maintain Validation Master Plan and change controls.
• Collaborate with Manufacturing, QA, and Engineering.
• Generate qualification reports and address non-conformances.

Skills

Validation

IQ/OQ/PQ

CSV

GAMP 5

Cross-functional Leadership

cGMP compliance

Documentation

Risk assessment

Education

Bachelor's in Engineering

Master’s degree preferred

Tools

eQMS

Regulatory databases

Job description

Weltraw Consulting Group in New Jersey seeks a senior Validation Engineer to manage, develop, and implement Equipment and Facility Validation programs to ensure GMP compliance and regulatory readiness. You will lead IQ/OQ/PQ protocols, perform CSV activities, review change controls, and partner with Manufacturing, QA, and Engineering to sustain a validated state across facilities and utilities.

Travel within 50 miles is required; a Bachelor's in Engineering or related field is necessary, with 5+