Technical Expert Elims Coe Qc Operations

Johnson & Johnson Johnson & Johnson · Pharma · Ringaskiddy, Cork, Ireland +1

This role focuses on configuring and maintaining the eLIMS system for Quality Control Operations in a regulated pharmaceutical environment. While the role involves using AI tools for efficiency and understanding AI concepts, its core function is not building or deploying AI models but rather managing laboratory information systems and ensuring compliance. The primary output is high-quality data configurations within the eLIMS system, which falls under data management for laboratory processes.

What you'd actually do

  1. ensure high-quality data eLIMS configurations that enable efficient, compliant, and paperless laboratory workflows, including product release and Certificate of Analysis generation.
  2. work independently to design, maintain, and continuously improve data setups while ensuring alignment with current business processes and regulatory requirements.
  3. act as a bridge between business and IT, translating laboratory needs into robust system solutions.
  4. integrating laboratory instruments and applications into the eLIMS system, reviewing and testing system updates, and creating and maintaining system documentation and standards.
  5. proactively find opportunities for process improvements and contribute to global harmonization and standardization efforts.

Skills

Required

  • bachelor’s degree or equivalent education
  • 4 to 6 years of experience in a regulated industry
  • strong experience with LIMS/eLIMS systems and quality environments
  • solid understanding of cGMP principles, FDA regulations, ICH guidelines (Q8, Q9, Q10), and risk management
  • organized, able to manage multiple priorities
  • comfortable working in a dynamic environment where flexibility is required
  • Strong communication skills in English (minimum level B2)
  • ability to effectively train and engage partners
  • strong customer focus
  • build trustful relationships across global teams
  • committed to delivering high-quality results
  • understanding of AI concepts and frameworks
  • awareness of responsible and ethical AI practices
  • comfortable using AI tools to enhance efficiency and productivity
  • ability to craft effective prompts to support day-to-day work

Nice to have

  • exposure to analytical testing, quality control, or IT

What the JD emphasized

  • regulated industry
  • cGMP principles
  • FDA regulations
  • ICH guidelines
  • risk management
  • AI concepts and frameworks
  • responsible and ethical AI practices
  • AI tools to enhance efficiency and productivity
  • craft effective prompts