Senior Validation Engineer - GMP CQV Specialist

Katalyst CRO; Rock Hill (SC); On-site; USD 110,000 - 150,000; Full time

Job summary

Katalyst CRO in Rock Hill, SC is seeking a Senior Validation Engineer to lead IQ/OQ execution, qualification of process equipment, and GMP/GDP-compliant documentation. You will collaborate with Engineering, QA, and Manufacturing to ensure validated systems perform reliably.

The role requires CQV experience, hands-on validation of bioprocess equipment, and the ability to support second-shift or weekend work as needed. This position emphasizes quality, compliance, and continuous improvement.

Qualifications

• Bachelor's degree in STEM or related technical discipline.
• 38 years of CQV or Validation Engineering experience in GMP-regulated environments.

Responsibilities

• Execute IQ/OQ protocols for process equipment and utilities.
• Perform drawing walkdowns and P&ID reviews for equipment installation.
• Support MOC activities and weld verification as part of validation.

Skills

IQ/OQ execution

P&ID reviews

MOC support

Temperature mapping

SIP/CIP validation

Deviation management

GMP/GDP compliance

Cross-functional collaboration

Education

Bachelor's degree in STEM or related

Tools

eVal

ValGenesis

Ellab

Job description

Katalyst CRO in Rock Hill, SC is seeking a Senior Validation Engineer to lead IQ/OQ execution, qualification of process equipment, and GMP/GDP-compliant documentation. You will collaborate with Engineering, QA, and Manufacturing to ensure validated systems perform reliably.

The role requires CQV experience, hands-on validation of bioprocess equipment, and the ability to support second-shift or weekend work as needed. This position emphasizes quality, compliance, and continuous improvement.