Onsite Validation Engineer - Pharma Equipment & Tanks (SC)

Katalyst CRO; Lafayette (IN); On-site; USD 90,000 - 120,000; Full time

Job summary

Katalyst CRO is seeking validation consultants for a 9-month onsite project in South Carolina. The role focuses on equipment qualification, tank qualification, mixing studies, smoke studies, aseptic technique, and instrument qualification.

You will lead validation execution, assess gaps, and guide strategies to ensure robust qualification packages. The engagement requires hands-on validation experience in pharmaceutical environments, strong IOQ/OQ/PQ knowledge, and the ability to drive

Qualifications

• Validation execution in pharma/biotech/aseptic environments.
• Strong IOQ/OQ/PQ knowledge and gap assessment ability.
• Experience with equipment and tank qualification.

Responsibilities

• Support validation execution and gap assessments on equipment qualification, tanks and mixing studies.
• Assist with aseptic processing validation and smoke study execution.
• Drive validation activities, coordinate resources, and maintain project momentum.
• Review and assess IOQ/OQ/PQ documentation for gaps and mitigation plans.
• Document protocols, results, and deviations to support compliance.

Skills

Validation execution

Equipment qualification

IOQ/OQ/PQ knowledge

Gap assessments

Aseptic processing

Smoke studies

Documentation

Project leadership

Education

Bachelor's degree

Job description

Katalyst CRO is seeking validation consultants for a 9-month onsite project in South Carolina. The role focuses on equipment qualification, tank qualification, mixing studies, smoke studies, aseptic technique, and instrument qualification.

You will lead validation execution, assess gaps, and guide strategies to ensure robust qualification packages. The engagement requires hands-on validation experience in pharmaceutical environments, strong IOQ/OQ/PQ knowledge, and the ability to drive