Senior MSAT Engineer
Listed on 2026-09-04
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Quality Assurance - QA/QC
Quality Engineering, Regulatory Compliance Specialist
Kelly® Science & Clinical is seeking a Senior MSAT Engineer for a 12-month contract position at a cutting-edge client in Houston, TX
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Pay: $60/hour
Schedule:
Mon-Fri Day Shift Onsite
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
- 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
- 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
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