Senior MSAT Engineer – Cell Therapy CAPA Lead (12mo)

Kelly Science, Engineering, Technology & Telecom; Houston (TX); On-site; USD 70,000 - 95,000; Full time

Job summary

Kelly® Science & Clinical is seeking a Senior MSAT Engineer for a 12-month contract in Houston, TX. The role focuses on owning deviations, investigations, CAPAs, and inspection readiness within a regulated biopharmaceutical setting.

You will partner with Manufacturing, QA, and technical teams to drive timely closures, perform root-cause analyses, and support process improvements and change controls. Onsite day shift in Houston.

Qualifications

• Bachelor’s degree in engineering, Life Sciences, or related field.
• 7+ years of biopharmaceutical manufacturing, MSAT, or process engineering experience.
• Direct cell therapy manufacturing experience required.
• Strong GMP technical writing and documentation skills.

Responsibilities

• Own and drive deviations, investigations, and CAPAs from initiation through closure.
• Support PLI-enabling CAPAs and inspection-readiness quality records.
• Lead root cause analysis, technical impact assessments, and corrective actions.
• Draft clear, inspection-ready investigation and CAPA documentation.
• Partner with Manufacturing, QA, and other technical functions to drive timely closure of quality records.
• Apply structured problem-solving and risk-assessment methodologies.
• Support MSAT activities including process troubleshooting, change controls, and continuous improvement.

Skills

MSAT

Biopharmaceutical manufacturing

Root cause analysis

Technical writing

Cross-functional collaboration

Education

Bachelor's degree in engineering or Life Sciences

Tools

Veeva eQMS

Job description

Kelly® Science & Clinical is seeking a Senior MSAT Engineer for a 12-month contract in Houston, TX. The role focuses on owning deviations, investigations, CAPAs, and inspection readiness within a regulated biopharmaceutical setting.

You will partner with Manufacturing, QA, and technical teams to drive timely closures, perform root-cause analyses, and support process improvements and change controls. Onsite day shift in Houston.