Lead Validation Engineer - Pharma Equipment & Aseptic QC

Katalyst CRO; Charleston (WV); On-site; USD 120,000 - 150,000; Full time

Job summary

Katalyst CRO is seeking validation consultants for a minimum 9-month on-site project in South Carolina. You will support validation execution and gap assessments across equipment and tank qualification, with emphasis on IOQ/OQ/PQ readiness and aseptic processing.

The role requires a strong understanding of validation strategies, the ability to drive the project, and experience in mixing studies and smoke studies within a pharmaceutical environment.

Qualifications

• Bachelor's degree or equivalent hands-on validation experience preferred.
• Experience supporting validation activities in pharmaceutical, biotech, or aseptic manufacturing environments.
• Strong knowledge of IOQ/OQ/PQ expectations and documentation.

Responsibilities

• Execute validation activities and gap assessments tied to equipment qualification and tank qualification.
• Evaluate mixing studies and assess equipment-based mixing qualification from IOQ to PQ.
• Support smoke study execution in aseptic processing environments and ensure proper aseptic technique.
• Identify gaps in qualification packages and provide mitigation recommendations to move the project forward.
• Drive project execution, coordinate with internal resources, and maintain project momentum.

Skills

Validation execution

Equipment qualification

IOQ/OQ/PQ concepts

Gap assessments

Tank qualification

Mixing study

Aseptic processing

Smoke study execution

Documentation

Mitigation strategies

Assertive project leadership

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 on-site project in South Carolina. You will support validation execution and gap assessments across equipment and tank qualification, with emphasis on IOQ/OQ/PQ readiness and aseptic processing.

The role requires a strong understanding of validation strategies, the ability to drive the project, and experience in mixing studies and smoke studies within a pharmaceutical environment.