Onsite Validation Engineer — Equipment & Gap Strategy

Katalyst CRO; Elmore (OH); On-site; USD 124,000 - 207,000; Full time

Job summary

Katalyst CRO seeks validation consultants for a 9-month onsite project in South Carolina. You will support validation execution and gap assessments across IOQ/OQ/PQ, tank qualification, mixing studies, and aseptic processing, with emphasis on tank validation and equipment qualification.

You will drive the project, guide internal resources, manage execution, and identify mitigation strategies for validation gaps in a fast-paced GMP environment.

Qualifications

• Validation execution in pharma/biotech/aseptic manufacturing.
• Understanding IOQ/OQ/PQ concepts and gaps.
• Tank qualification and mixing qualification experience.
• Ability to perform gap assessments and mitigation strategies.

Responsibilities

• Lead onsite validation execution for a 9-month project.
• Conduct gap assessments and guide validation strategy.
• Oversee IOQ/OQ/PQ alignment for tanks and equipment.
• Drive execution, manage resources, and maintain progress.

Skills

Validation execution

Equipment qualification

IOQ/OQ/PQ

Gap assessment

Aseptic processing

Smoke study

Project leadership

Education

Bachelor's degree in Engineering/Science

Job description

Katalyst CRO seeks validation consultants for a 9-month onsite project in South Carolina. You will support validation execution and gap assessments across IOQ/OQ/PQ, tank qualification, mixing studies, and aseptic processing, with emphasis on tank validation and equipment qualification.

You will drive the project, guide internal resources, manage execution, and identify mitigation strategies for validation gaps in a fast-paced GMP environment.