Sr MSAT Engineer

12-month contract position in Houston, TX (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.

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

Requirements

• 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 Qualifications

• 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

Pay

$60/hour

Schedule

Mon-Fri Day Shift (onsite)

Benefits

• Voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, and a legal plan
• Retirement savings plan
• Service bonus and holiday pay plans (earn up to eight paid holidays per benefit year)
• Transit spending account
• Paid sick leave under the applicable state or local plan