Onsite Validation Lead: Equipment & Tank Qualification

Katalyst CRO; City of Rochester (NY); On-site; USD 90,000 - 130,000; Full time

Job summary

Katalyst CRO is seeking validation consultants for a minimum 9-month onsite project in the United States. The role focuses on validation execution, equipment qualification, tank qualification, and mixing studies, with emphasis on aseptic technique and smoke study execution.

The ideal candidate will assess IOQ/OQ documentation, identify gaps between OQ and PQ, and determine whether current qualifications can support PQ expectations.

Qualifications

• Bachelor's degree in Engineering, Science, Life Sciences, or related technical discipline preferred; equivalent hands-on validation experience considered.
• Must have validation execution experience in pharmaceutical, biotech, or aseptic manufacturing environments.
• Strong understanding of IOQ/OQ/PQ expectations and ability to perform gap assessments.
• Tank qualification and mixing study experience or strong understanding of equipment-based mixing qualification.
• Experience with aseptic processing and smoke studies; capable of driving validation execution as a representative.

Responsibilities

• Support validation execution and gap assessments tied to equipment qualification, tank qualification, mixing studies, smoke studies, aseptic technique, and instrument/equipment qualification.
• Assist in evaluating IOQ/OQ documentation, identify gaps between OQ and PQ, and determine whether current qualifications support PQ expectations.
• Support product-specific mixing studies from an equipment qualification perspective and assess viscosity, matrix/bracketing, and risk-related gaps.
• Drive execution, guide internal resources, and keep the validation effort moving forward as a validation lead.

Skills

Validation execution

Equipment qualification

IOQ/OQ/PQ

Gap assessments

Aseptic processing

Smoke study

Documentation

Education

Bachelor's degree in Engineering, Science, Life Sciences, or related technical discipline

Job description

Katalyst CRO is seeking validation consultants for a minimum 9-month onsite project in the United States. The role focuses on validation execution, equipment qualification, tank qualification, and mixing studies, with emphasis on aseptic technique and smoke study execution.

The ideal candidate will assess IOQ/OQ documentation, identify gaps between OQ and PQ, and determine whether current qualifications can support PQ expectations.