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Project Engineer (NPI)

  • Job reference: 926844
  • Location: Cork
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Engineering, Manufacturing & Facilities, Life Sciences
  • Date posted: 31/07/2019

Orion Group are looking for a Project Engineer (NPI) for our multinational medical devices client based in the Cork area on an initial 12-month contract with the potential to extend.


Job Purpose
On a daily basis, your work in NPI will interact with H&S, Quality, Operations, Product Design and global packaging teams to develop this process to market launch.


Main Responsibilities of the role

  • Process development including PFMEA
  • Process Characterisation through engineering studies
  • Process Qualification/Validation
  • Planning & execution of key deliverables & action plans with the help of the Project Manager
  • Regular reporting on the status, performance and risks of your project
  • Participate in DFM reviews with Design Team to minimize lifecycle cost
  • Minimise Environmental and Health & Safety effects of your work
  • Adhere to the company's procedures as detailed in the SOP manual
  • Support Regulatory Affairs with product submissions
  • All other duties as directed by direct manager

Desired Experience and Background of the successful candidate

  • Third level degree in Engineering or similar discipline
  • 1-3 years' experience in equipment installations/facilities/commissioning
  • Self-motivated, with focus on H&S, Quality, Delivery and Cost
  • Proven Root Cause analysis and problem-solving techniques
  • 1-3 years' experience in equipment operation/installation/qualification in a regulated environment
  • Exposure to Project Management methodologies
  • Knowledge of medical device or pharmaceutical industries
  • Technical leadership
  • Prior experience in a GMP or medical device manufacturing environment
  • Prior experience in equipment and process validation activities
  • Process development experience
  • Equipment conceptual skills
  • Experience of bespoke capital equipment
  • A strong team player that will own the delivery of elements within their process/technology area
  • Strong interpersonal skills, be able to collaborate effectively to resolve technical challenges
  • Knowledge/experience in sterility assurance is an advantage
  • Knowledge of equipment and process validation and documentation procedures and processes

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.

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