Process Engineer

Johnson & Johnson Johnson & Johnson · Pharma · Limerick, Ireland

Process Engineer at Johnson & Johnson in Limerick, Ireland, responsible for planning, executing, and delivering engineering activities within a manufacturing value stream. This role involves technical leadership to improve safety, quality, delivery, and cost, supporting new product introductions, process changes, and compliance in a highly regulated (GMP/ISO/FDA) environment. Key responsibilities include managing change control, validation (IQ/OQ/PQ), technical investigations, and driving continuous improvement initiatives in collaboration with cross-functional teams.

What you'd actually do

  1. Plans and executes moderately complex engineering and/or change control projects requiring conceptual evaluation, design, and validation.
  2. Plans and executes qualification of new or modified equipment, controls, systems, and/or processes; supports vendor and site acceptance testing as required.
  3. Identifies and implements equipment, process, packaging, and/or materials enhancements to improve efficiency, yield, reliability, and safety.
  4. Performs structured problem solving and root cause analysis for deviations, nonconformances, audit actions, and CAPAs.
  5. Ensures compliance with applicable GMP, ISO, FDA, and company requirements.

Skills

Required

  • Bachelor’s degree in Engineering or related technical discipline
  • 2–4 years relevant engineering experience in manufacturing or regulated industry environments
  • Demonstrated project execution experience

Nice to have

  • Experience in ISO/FDA regulated environments
  • Experience with qualification, validation, and change control activities
  • Exposure to Lean, Six Sigma, or structured problem‑solving methodologies
  • Strong analytical and problem-solving skills
  • Demonstrated technical writing and GDP discipline
  • Effective communication and collaboration skills in matrix environments
  • Strong organizational skills and ability to manage multiple priorities
  • Working knowledge of project management fundamentals
  • Proficiency with common office and data analysis tools

What the JD emphasized

  • highly regulated (GMP/ISO/FDA) environment
  • validation and qualification activities (IQ/OQ/PQ)
  • change control