Senior Process Engineer – CQV Validation Lead

Validation & Engineering Group, Inc.; Town of Florida (NY); On-site; USD 120,000 - 170,000; Full time

Job summary

Validation & Engineering Group, Inc. in the United States seeks a Senior Process Engineer / CQV Validation Engineer to independently drive process engineering, qualification, validation, and GMP documentation while supporting manufacturing operations and strategic projects.

This hands-on role emphasizes IQ/OQ/PQ protocol development, equipment qualification, system verification, and collaboration with Manufacturing, Quality, and Engineering teams to deliver compliant, timely project

Qualifications

• Minimum 5 years of experience in Process Engineering, Validation, CQV, Manufacturing Engineering, or related discipline.
• Experience in FDA-regulated environments (Medical Device, Pharmaceuticals, or biotech).
• Strong knowledge of GMP requirements and regulated documentation practices.
• Hands-on experience with IQ/OQ/PQ protocols and process validation.
• Proven ability to lead root-cause investigations and change controls.

Responsibilities

• Lead manufacturing process characterization studies and data analysis.
• Develop and execute IQ, OQ, and PQ protocols; qualify equipment and systems.
• Lead validation planning, execution, data analysis, and reporting.
• Provide commissioning, qualification support, and deviations management.
• Prepare validation summary reports, risk assessments, and final deliverables.
• Collaborate with Manufacturing, Operations, Engineering, Maintenance, and Quality teams.

Skills

Process engineering

CQV

GMP documentation

Analytical thinking

Technical writing

Education

Bachelor's degree in Engineering or equivalent

Job description

Validation & Engineering Group, Inc. in the United States seeks a Senior Process Engineer / CQV Validation Engineer to independently drive process engineering, qualification, validation, and GMP documentation while supporting manufacturing operations and strategic projects.

This hands-on role emphasizes IQ/OQ/PQ protocol development, equipment qualification, system verification, and collaboration with Manufacturing, Quality, and Engineering teams to deliver compliant, timely project