Onsite Validation Engineer – Pharma Equipment & Aseptic

Katalyst CRO; Raleigh (NC); On-site; USD 90,000 - 130,000; Full time

Job summary

Katalyst CRO is seeking validation consultants for a 9-month onsite project in South Carolina. The role focuses on validation execution and gap assessments across equipment, tank, and mixing studies, with emphasis on aseptic processing and aseptic technique.

The lead consultant will drive the project, guide internal resources, and ensure timely progression of validation activities. Responsibilities include evaluating IOQ/OQ documentation, bridging gaps to PQ, and advising on robust qualification

Qualifications

• Bachelor's degree in Engineering, Science, Life Sciences, or related technical discipline preferred.
• Hands-on validation experience in pharma/biotech environments are a plus.
• Experience supporting IOQ/OQ/PQ activities and gap assessments is required.

Responsibilities

• Support validation execution and gap assessments tied to equipment qualification, tank qualification, mixing studies, smoke studies, aseptic technique, and instrument qualification.
• Drive project execution, guide internal resources, and maintain progress on validation deliverables.
• Assess IOQ/OQ documentation for robustness and identify gaps between OQ and PQ.
• Provide guidance on validation strategies and mitigation of identified gaps.

Skills

Validation execution

Gap assessment

Project leadership

Aseptic processing

Tank qualification

IOQ/OQ/PQ

Mixing study

Documentation

Education

Bachelor's degree in Engineering or Life Sciences

Job description

Katalyst CRO is seeking validation consultants for a 9-month onsite project in South Carolina. The role focuses on validation execution and gap assessments across equipment, tank, and mixing studies, with emphasis on aseptic processing and aseptic technique.

The lead consultant will drive the project, guide internal resources, and ensure timely progression of validation activities. Responsibilities include evaluating IOQ/OQ documentation, bridging gaps to PQ, and advising on robust qualification