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Project Engineer

  • Sector: Engineering
  • Contact Email:
  • Job Ref: 21744

Project Engineer

The scope of this role will require the successful candidate to work on projects across 2 facilities within 1 hour commutable distance from each other. The role will predominately site based with some flexibility to work from home occasionally.

As Project Engineer you will be involved in identifying and implementing process improvements and complete the validation assessment and implementation of changes to automated equipment. The incumbent will help identify areas of process improvement in our production processes and ensure that the assigned areas of validation are effectively managed, and all elements follow the requirements specified by the Quality System and the relevant international standards. The individual will drive OEE improvement initiatives as well as preparing, drafting and execution of validation protocols and reports.

Primary Job Function:

  • Development of the validation strategy for changes to automated equipment and gain agreement with stakeholders including Owner, Technical and Quality on approach.

  • Drives Process Improvement efforts. Identifies opportunities to improve process capability, robustness, and efficiency. Detects and isolates sources of variation in processes. Utilizes Root Cause Analysis, Lean manufacturing, and Six Sigma tools in decision making.

  • Orchestrates validation activities. Works with cross functional teams to validate automated processes. Completes risk analysis (through FMEA and other risk analysis tools) to identify process and equipment risk areas. Develops protocols for testing equipment. Executes test plans, and documents results in validation reports. Develops statistically sound sampling plans and incorporates statistical analysis on results to confidently reach data driven conclusions.

  • Documenting and Managing Change - Justifies changes, quality and regulatory information, and manufacturing readiness information. Executes changes through the quality system to properly implement project outcomes.

  • Collaborates across functional areas - Interprets; presents; and delivers information with senior team members; scientists; engineers; and other systems development personnel across sites. Works with cross functional team in collaborative environment.

  • Complete all activities in a safe manner, ensuring that any potential safety issues and areas for improvement are addressed.

Experience / Qualifications

Bachelor’s Degree in Engineering or technical discipline, plus demonstrated competence  

Two years progressive work experience in Engineering/Process Improvement role with validation experience

Experience in some or all of the following areas would be beneficial;

  • Validation of automated processes for medical devices

  • Lean Six Sigma experience

  • Project Management

  • Troubleshooting and problem resolution

  • Development of assembly automation solutions, robotics, and complex machine controls preferred.


For a confidential discussion and more information on the role, please contact Davin Ferguson

071 9140251