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Project Engineer NPI

  • Job reference: 930754
  • Location: Cork
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Engineering, Manufacturing & Facilities, Life Sciences
  • Date posted: 14/04/2020

Orion Group Life Sciences have an exciting opportunity for a Project Engineer NPI for our Multinational Medical Devices client based in the Cork area on an initial 12-month contract.

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. You will be responsible for the clean and pack process for multiple projects with the support of existing experience clean & pack engineers in the NPI department. You will develop, qualify & launch the Clean & Pack process as part of the Core Team.

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
  • Exposure to Project Management methodologies
  • Knowledge of medical device or pharmaceutical industries
  • A planned and organised individual with strong technical or process knowledge/experience in cleaning & packaging within a regulated industry
  • A strong team player that will own the delivery of elements within their process/technology area
  • You will need strong interpersonal skills, be able to collaborate effectively to resolve technical challenges
  • Knowledge/experience in sterility assurance is an advantage
  • 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
  • Ability to organise medium complexity technical issues
  • Knowledge of equipment and process validation and documentation procedures and processes
  • Ability to take ownership
  • Develop good working relationships across the business
  • Ability to motivate and lead - must be team orientated
  • Honest, open, flexible approach

    #medicaldevices #medical #device #13485 #multinational #product #implant #engineering #NPI

For more information on this role, call Daniel Ryan on +353868140295 or email for a completely confidential chat about this role and other opportunities using the reference number: 930754

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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