Cell Therapy Root-Cause Analyst & Technical Writer

TechDigital Group; Libertyville (IL); On-site; USD 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a skilled MSAT Technical Writer to support the manufacturing of cell therapy vectors. In this role, you will investigate and write root cause analyses for non-conformance events, working closely with quality partners and process engineers. Your expertise in technical writing and scientific acumen will be vital in analyzing manufacturing data and summarizing findings to ensure compliance with GMP standards. If you are passionate about biopharmaceuticals and enjoy solving complex problems, this position offers a unique opportunity to contribute to innovative therapies that make a difference in patients' lives.

Qualifications

• 3+ years in drug product biopharmaceutical or equivalent industry.
• Strong technical writing and scientific skills required.

Responsibilities

• Facilitates deviation closure with quality partners.
• Analyzes manufacturing data for root cause investigations.
• Writes thorough technical investigation reports.

Skills

Technical Writing

Root Cause Analysis

Complex Problem-Solving

Scientific Acumen

Prioritization

Education

BS in Bio/Chem Science/Engineering

Immunology Education

Tools

GMP Quality Systems

Root Cause Analysis Tools

Job description

Education & Experience Required:
Graphics Core skills

• Embedded graphics development experience using OpenGL.
• Epic Deos experience - preferred.

Platform Core skills

• Multi-Core Processor Architecture (General Understanding)
  • Strong fundamentals of multi-core processing concepts and system-level behavior.
• Processor and Memory Architecture
  • In-depth knowledge of shared memory access across multiple cores, including GPU interaction:
    • Memory Controller design and operation
    • Cache memory hierarchy (L1, L2, L3, etc.)
    • Main memory systems (e.g., DDR)
• Shared Resource Monitoring and Analysis
  • Understanding of monitoring mechanisms for shared resource usage, including:
    • Performance counters
    • Quality of Service (QoS) mechanisms
    • Techniques for Worst-Case Execution Time (WCET) computation
• WCET Analysis with Interference Considerations
  • Capability to analyze WCET under the influence of various interference channels such as:
    • I/O subsystems
    • GPU
    • SSD
    • FPGA
    • Other shared resources
• DEOS Expertise
  • Practical knowledge of DEOS (or equivalent RTOS), with a focus on:
    • Cache partitioning techniques
    • Resource isolation and management
• Regulatory Knowledge
  • Familiarity with AC 20-193 (FAA guidance on multi-core processor certification) is a strong advantage.