MSAT Sr. Engineer

Role Summary

The MSAT Senior Engineer provides technical leadership for cell therapy manufacturing operations, ensuring processes are robust, scalable, and compliant with GMP standards. The role plays a critical part in technology transfer, process improvement, facility start-up, and regulatory readiness, supporting both clinical and commercial production.

Responsibilities

• Project & Facility Support
• Lead or support projects to improve process robustness, scalability, and GMP compliance.
• Contributes to the construction, qualification, and start-up of new commercial manufacturing facilities.
• Author, review, and approve technical documentation including project plans, test protocols, reports, and SOPs.
• Technical Process Support
• Serve as the MSAT point-of-contact for development, manufacturing, supply chain, QC, QA, and vendor projects.
• Provide hands-on technical support for cell processing operations, including troubleshooting and optimization.
• Lead investigations for process deviations, perform root cause analyses, and implement corrective/preventive actions (CAPAs).
• Data & Compliance
• Analyze process and project data, presenting clear findings and recommendations to stakeholders.
• Ensure compliance with cGMP, safety standards, and company SOPs.
• Support regulatory submissions by preparing technical documentation and data summaries.
• Act as a subject matter expert (SME) during inspections and audits.
• Risk & Material Management
• Identify risks in manufacturing processes and implement mitigation strategies.
• Assess and qualify raw materials, ensuring suitability, reliability, and supply chain continuity.

Qualifications

• 8+ years with a Bachelor’s or 6+ years with a Master’s in MSAT, cell therapy, or biopharmaceutical manufacturing.
• Proven leadership in GMP project implementation, technology transfer, and process troubleshooting.
• Experience with process validation and lifecycle management preferred.
• Strong understanding of cell therapy or biopharmaceutical processes, including aseptic processing, cell expansion, and purification.
• Familiarity with GMP, GLP, and regulatory requirements for cell-based therapies.
• Experience supporting regulatory submissions and audits.
• Experience handling human-derived materials in cleanroom environments.
• Familiarity with MES or ERP systems.
• Knowledge of ICH guidelines (Q8, Q9, Q10) and Quality by Design (QbD) principles.
• Excellent problem-solving, analytical, and critical-thinking abilities.
• Strong communication and technical writing skills (SOPs, batch records, reports).
• Ability to work effectively in cross-functional, fast-paced environments.

Education

• Bachelor’s or master’s degree in chemical engineering, Biochemical engineering, Biotechnology, or related discipline

Additional Requirements

• Flexibility to occasionally support weekend manufacturing operations.