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Process Engineer -NPI

  • Location: County Westmeath
  • Job Type:Permanent
  • Sector: Engineering
  • Contact Email: paul.dunican@collinsmcnicholas.ie
  • Job Ref: 22917

Our client is a leading player in the medical device industry, committed to driving innovation and ensuring the highest standards of safety and quality. They are currently seeking a dedicated and experienced Process Engineer -NPI (New Product Introduction) to join their dynamic team.

The role will focus particularly on supporting the project team in validation and SOP documentation preparation as well as change control requests. Collaborate with other departments to ensure requirements of Safety, Quality, Cost, and Service are achieved.

Job Responsibilities:

  • Provide engineering support for new equipment and process changes, ensuring that all activities are completed and documented in accordance with regulatory requirements

  • Write and edit standard operating procedures, test methods, technical/validation reports, regulatory submissions, investigations, and other related documents (VP, IQ, OQ, URS, etc.)

  • Evaluate process layouts in terms of supporting new process integration while ensuring the best utilization of floor space ensuring optimum process flow

  • Support budgetary, scheduling, and project databases, and report regularly to the project manager on progress as well as on problems that could significantly affect cost or schedule

  • Development of appropriate supporting documentation, SOPs, PFMEA, Control Plans, and process work instructions compliant with current Good Manufacturing Practices (GMP)

  • Transferring and implementing processes, either from development or from another manufacturing facility

  • Partner with technical leadership and cross-functional partners such as Manufacturing, Quality, Engineering, Finance, and Facilities to implement appropriate written documentation

  • Work with initiators to rewrite, clarify, or reconstruct controlled documents and investigations.

  • Developing specifications in the form of a URS for new equipment purchases

  • Conduct MSA studies for products and new processes

  • Responsible as technical lead for projects (value stream and cross-functional) as assigned by the company, including the scoping, approval, budgeting, specification, execution, qualification, and operational handover as appropriate

  • Observing the Quality Management Systems requirements on-site at all times

Job Requirments:

  • Third Level Qualification in relevant Engineering Degree

  • Minimum 3 Years Experience in a GxP environment

  • Strong Communication and influencing skills with both internal and external agents

  • Six Sigma/Lean Expertise demonstrated in manufacturing, Process Development, and validation of new products is desired

  • Demonstrable analytical & problem-solving skills, a process improvement orientation, and the ability to handle multiple tasks in a fast-paced and results-oriented environment

If you would like more information on this role you can contact Paul Dunican

paul.dunican@collinsmcnicholas.ie

(090) 641 7022