Senior MSAT Engineer

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 position at a cutting-edge client in Houston, TX. If you're passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

Pay: $60/hour

Schedule: Mon-Fri Day Shift Onsite

Overview

Our client is an industry-leading company at the forefront of cell therapy manufacturing and CMC-GMP operations. This is a unique opportunity to join a cutting-edge organization where you will play a critical role in supporting quality records and PLI inspection readiness within a fast-paced, highly regulated biopharmaceutical environment.

In this role, you will be responsible for owning and driving deviations, investigations, and CAPAs from initiation through closure, while partnering cross-functionally with Manufacturing, QA, and other technical teams. You will apply structured problem-solving methodologies, draft inspection-ready technical documentation, and support broader MSAT activities including process troubleshooting, change controls, and continuous improvement initiatives.

Responsibilities:

• Own and drive deviations, investigations, and CAPAs from initiation through closure
• Support execution of PLI-enabling CAPAs and other inspection-readiness quality records
• Lead root cause analysis, technical impact assessments, and development of corrective actions
• Draft clear, technically sound, 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 broader MSAT activities as needed, including process troubleshooting, process assessments, change controls, manufacturing support, and continuous improvement

Qualifications:

• Bachelor’s degree in engineering, Life Sciences, or a related technical field
• 7+ years of relevant biopharmaceutical manufacturing, MSAT, or Process Engineering experience
• Direct cell therapy manufacturing experience required
• Strong experience owning deviations, investigations, and CAPAs in a cGMP environment
• Excellent GMP technical writing and documentation skills
• Strong root cause analysis and cross-functional problem-solving capability
• Ability to work independently and manage multiple time-sensitive priorities

Preferred:

• Autologous cell therapy experience
• Late-stage, pivotal, or commercial manufacturing/MSAT experience
• PLI / inspection-readiness experience
• Veeva or other electronic Quality Management System (eQMS) experience
• Houston-area based