Sr MSAT Engineer

Kelly Services; Stafford (TX); On-site; USD 172,200,000 - 199,752,000; Full time

Job summary

Kelly Science & Clinical in Houston, TX is seeking a Senior MSAT Engineer for a 12-month contract. You will own deviations, investigations, and CAPAs, and drive inspection readiness across cross-functional teams in a fast-paced biopharmaceutical setting.

Responsibilities include leading RCA, preparing technical documentation, and supporting process troubleshooting and continuous improvement initiatives aligned with cGMP requirements.

Qualifications

• 7+ years in biopharmaceutical manufacturing, MSAT or process engineering.
• Direct cell therapy manufacturing experience required.
• Excellent GMP writing and documentation skills.

Responsibilities

• Own deviations, investigations, and CAPAs from initiation to closure.
• Support inspection-readiness quality records and PLI-enabling CAPAs.
• Lead root cause analysis and risk assessments with cross-functional teams.
• Draft inspection-ready technical documentation for investigations and CAPAs.
• Collaborate with Manufacturing, QA and other technical functions to close quality records.

Skills

7+ years MSAT/Process Engineering

Root cause analysis

CAPA management

Cross-functional collaboration

Education

Bachelor's degree in engineering or Life Sciences

Tools

Veeva or eQMS

Job description

Senior MSAT Engineer

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