Technical Expert Elims Coe Qc Operations

Johnson & Johnson Johnson & Johnson · Pharma · Raritan, NJ +4

This role is for a Technical Expert in eLIMS within the Quality Control Operations at Johnson & Johnson Innovative Medicine. The primary focus is on configuring and maintaining the eLIMS system to ensure efficient, compliant, and paperless laboratory workflows for product release and CoA generation. The role involves bridging business and IT, integrating instruments, testing system updates, and ensuring adherence to cGMP and regulatory requirements. While the role requires an understanding of AI concepts and the ability to use AI tools for efficiency, its core function is not AI/ML development but rather the management and optimization of laboratory information systems.

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. act as a bridge between business and IT, translating laboratory needs into robust system solutions.
  3. integrating laboratory instruments and applications into the eLIMS system, reviewing and testing system updates, and creating and maintaining system documentation and standards.
  4. proactively find opportunities for process improvements and contribute to global harmonization and standardization efforts.
  5. lead or contribute to projects within QC Operations, such as continuous improvement initiatives related to the iLAB’s Base Business process.

Skills

Required

  • Bachelor's degree or equivalent education
  • 4 to 6 years of experience in a regulated industry (pharmaceuticals, medical devices, or diagnostics)
  • Strong experience with LIMS/eLIMS systems and quality environments
  • Solid understanding of cGMP principles, FDA regulations, ICH guidelines (Q8, Q9, Q10), and risk management
  • Strong communication skills in English (minimum level B2)
  • Ability to effectively train and engage partners
  • Strong customer focus
  • Ability to build trustful relationships across global teams
  • Commitment to delivering high-quality results
  • Understanding of AI concepts and frameworks, including awareness of responsible and ethical AI practices
  • Comfortable using AI tools to enhance efficiency and productivity, including the ability to craft effective prompts to support day-to-day work

Nice to have

  • Exposure to analytical testing, quality control, or IT
  • Analytical Reasoning
  • Business Alignment
  • Business Behavior
  • Coaching
  • Collaborating
  • Communication
  • Compliance Management
  • Data Compilation
  • Data Quality
  • Data Savvy
  • Document Management
  • Problem Solving
  • Quality Auditing
  • Quality Control (QC)
  • Quality Management Systems (QMS)
  • Quality Services
  • Quality Standards
  • Systems Analysis
  • Training People

What the JD emphasized

  • eLIMS
  • 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 to support day-to-day work