Onsite Validation Lead: Equipment, Tank & Aseptic Studies

Katalyst CRO; Rock Hill (SC); On-site; USD 90,000 - 130,000; Full time

Job summary

Katalyst CRO seeks validation consultants for a 9-month onsite project in South Carolina. You will support validation execution, gap assessments, and tank qualification focused on drug substance mixing and drug product filling, with emphasis on aseptic technique and smoke studies.

The role requires hands-on validation experience in pharma/biotech settings, strong IOQ/OQ/PQ knowledge, and the ability to drive activities and mitigate gaps while coordinating with client teams.

Qualifications

• Validation execution experience in pharmaceutical/aseptic environments.
• Strong understanding of IOQ/OQ/PQ expectations.
• Ability to perform gap assessments and mitigation strategies.
• Tank qualification and mixing study experience.

Responsibilities

• Execute validation activities onsite in South Carolina for a 9-month project.
• Support IOQ/OQ/PQ gap analysis and documentation.
• Lead or assist in tank qualification, mixing studies and equipment qualification.
• Support smoke studies in aseptic processing environments.
• Drive project progress and coordinate with internal resources.

Skills

Validation execution

Equipment qualification

IOQ/OQ/PQ understanding

Gap assessments

Tank qualification

Mixing study

Aseptic processing

Smoke study execution

Documentation

Education

Bachelor's degree in Engineering/Science

Tools

IOQ

Job description

Katalyst CRO seeks validation consultants for a 9-month onsite project in South Carolina. You will support validation execution, gap assessments, and tank qualification focused on drug substance mixing and drug product filling, with emphasis on aseptic technique and smoke studies.

The role requires hands-on validation experience in pharma/biotech settings, strong IOQ/OQ/PQ knowledge, and the ability to drive activities and mitigate gaps while coordinating with client teams.