Process Engineer

Johnson & Johnson Johnson & Johnson · Pharma · Nijmegen, Netherlands

Process Engineer role at Johnson & Johnson in Nijmegen, Netherlands, focusing on technical leadership for manufacturing processes and equipment. Responsibilities include improving safety, quality, yield, and capacity; driving change control and process validation; supporting problem-solving for deviations; and continuous improvement initiatives within a regulated manufacturing environment.

What you'd actually do

  1. Identifying improvement opportunities and participating in project to enhance safety, quality, yield and efficiency.
  2. Monitoring, and reporting key performance indicators (KPIs) for process performance, equipment utilization, downtime, scrap, and yield; drive actions based on performance and risk.
  3. Supporting manufacturing equipment and process validation/qualification activities, including creating validation strategies and plans; defining requirements (URS) and supporting supplier acceptance (FAT/SAT) and execution of IQ/OQ/PQ; author/review protocols and reports in line with GMP and ISO 13485 expectations.
  4. Supporting and executing change controls.
  5. Participating in problem solving and providing hands-on technical support to operations by troubleshooting process deviations, equipment failures, and yield losses using structured root-cause analysis and supporting robust corrective actions.

Skills

Required

  • Bachelor’s degree in Engineering (Mechanical, Manufacturing, Biomedical, Chemical) or related technical discipline.
  • Experience in a regulated manufacturing environment (Class III sterile medical devices preferred); working knowledge of ISO 13485 and ISO 14971; familiarity with FDA QSR/QMSR is a plus.
  • Minimum 3 years of process engineering experience in manufacturing, including hands-on troubleshooting and implementation in a production environment.
  • Demonstrated experience with change control, deviation/nonconformance investigations, CAPA, and engineering documentation (protocols, reports, work instructions) in an ISO/GMP environment.
  • Knowledge of equipment specification and qualification (URS, FAT/SAT, IQ/OQ/PQ).
  • Working knowledge of risk management and statistical/quality tools (e.g., PFMEA, control plans, DOE, SPC, capability analysis, MSA/Gage R&R) to support robust process control.
  • Fluency in English; Dutch is preferred.
  • Cross-functional collaboration skills (Operations, Quality, Technical Operation, R&D, Supply Chain, suppliers) with the ability to influence without authority.
  • Demonstrated ability to work in accordance with procedures, maintain high documentation quality, and manage multiple priorities in a fast-paced, regulated environment.
  • Good communication, stakeholder management, and technical leadership skills with the ability to build trust at all levels.

Nice to have

  • Dutch is preferred

What the JD emphasized

  • regulated manufacturing environment
  • ISO 13485
  • GMP