Manufacturing Engineer

Johnson & Johnson Johnson & Johnson · Pharma · Groningen, Netherlands

Manufacturing Engineer at Johnson & Johnson focused on production capability, equipment reliability, and on-time delivery within a highly regulated healthcare environment. Responsibilities include process analysis, risk assessment, developing and improving processes/equipment, validation studies, and implementing technical solutions. Requires experience in manufacturing/industrial engineering, problem-solving methodologies, GMP/GXP, and SCADA systems.

What you'd actually do

  1. Analyze and assess product and process requirements (materials, process, quality, EHS, product specifications) and perform risk and root cause analysis
  2. Develop, improve, characterize and design new or improved processes, equipment or test methods. Define requirements specifications and write (or support the writing of) the necessary supporting documentation (URS, TM, FAT, IQ OQ, PQ) for their implementation.
  3. Organize engineering, validation and verification studies by setting up a test plan and protocol, test criteria, executing tests, analyzing, interpreting and reporting outcomes as well as identifying and solving technical issues.
  4. Keep up with relevant engineering methods, tools and technologies in the market and develop, improve, validate and implement new and existing methods, tools, technologies, procedures and protocols, specifically in the field of control systems.
  5. Plan, organize and evaluate the implementation of new assets & process, including writing, standard operating procedures (SOP’s), protocols and procedures, risk assessments and training of employees.

Skills

Required

  • Bachelor of Science in relevant subject (E.g. Electrical / Systems / Automation Engineering)
  • Minimum of 3-5 years of experience in a Manufacturing and/or Industrial Engineering role in medium to high volume manufacturing
  • Verbal and written proficiency (at least at B2 level) in English
  • Demonstrated knowledge in problem-solving methodology (DOE, Process Capability Analysis, Hypothesis Test Methods)
  • Knowledge & application experiences of GMP, GXP fundamentals
  • Hands-on mentality and strong collaboration with all teams
  • Proven track record as within a medtech, pharma or other highly regulated (cGMP) sector.
  • Experience of SCADA system deployment & validation
  • familiar with change control and are capable and comfortable in conducting validation activity from the creation of CR, URS, VP, etc incl. creating and execution of test protocols, Writing reports of protocol outputs. Up to the closure of VSR and CR with support from validation experts.

Nice to have

  • Advanced degree (MSc. or PhD) in relevant subject is desired
  • Proficient in applying of statistical metho

What the JD emphasized

  • highly regulated (cGMP) sector
  • highly regulated environment
  • validation activity