9-Month Onsite Validation Lead - Tanks & Aseptic

Katalyst CRO; San Francisco (CA); On-site; USD 95,000 - 120,000; Full time

Job summary

Katalyst CRO seeks validation consultants for a minimum 9-month onsite project in South Carolina. You will support validation execution, gap assessments, and qualifications (IOQ/OQ/PQ) for tanks, mixing, and aseptic equipment, aligning with audit findings and improving the site validation program.

Responsibilities include guiding internal resources, driving the project forward, and ensuring robust qualification documentation and mitigation of gaps through effective strategies.

Qualifications

• Bachelor's degree in Engineering, Science, Life Sciences, or related technical discipline preferred.
• Equivalent hands-on validation experience can be considered.

Responsibilities

• Support validation execution and gap assessments tied to equipment qualification, tank qualification, mixing studies, smoke studies, aseptic technique, and instrument/equipment qualification.
• Assess IOQ/OQ documentation robustness and gaps between OQ and PQ.
• Support product-specific mixing study needs and mixing from an equipment qualification perspective.
• Drive smoke study execution in aseptic processing environment, understanding aseptic technique and equipment operation.
• Lead consultant to drive project, guide resources, manage execution, and move validation forward.

Skills

Validation execution

Tank qualification

IOQ/OQ/PQ understanding

Aseptic processing

Smoke study execution

Gap assessment

Documentation

Education

Bachelor's degree in Engineering/Science/Life Sciences or related field

Tools

Qualification protocols

Job description

Katalyst CRO seeks validation consultants for a minimum 9-month onsite project in South Carolina. You will support validation execution, gap assessments, and qualifications (IOQ/OQ/PQ) for tanks, mixing, and aseptic equipment, aligning with audit findings and improving the site validation program.

Responsibilities include guiding internal resources, driving the project forward, and ensuring robust qualification documentation and mitigation of gaps through effective strategies.