Reference Code
DU19242

We are currently recruiting for a Project Engineer for a role based with our client in Louth

The purpose of this role is to design, lead, coordinate and deliver a suitable packaging and sterilisation solution for sterile products suitable for kit packing.

Responsibilities

  • Evaluation of raw materials for trials
  • Project planning
  • Trial execution of packaging alternatives and steriliser cycles
  • Preparation of product for ship testing
  • Defining optimal process parameters for equipment
  • Ensure compliance with ISO 13485 for Medical Device Manufacturing Systems, ISO 17665 for Steam Sterilization, US Pharmacopeia and the impending ISO 22519 for purified water and water for injection pre-treatment and production systems
  • Work creatively and analytically in a problem-solving environment demonstrating teamwork, innovation and excellence
  • Manage project scope and changes while acting as an internal quality control check for delivery of suitable packaging alternatives and steam sterilization options
  • Develop and deliver progress reports, proposals, requirements, documentation and presentations to various audiences, including project teams, sponsors and key stakeholders

Background/Qualifications & Experience

  • Minimum NFQ Level 8 qualification in Engineering or Science
  • 5 – 10 years’ Pharmaceutical or Medical Device manufacturing experience (or closely related)
  • Experience with moist heat sterilisation technologies including steam systems and pre-treatment systems
  • Knowledge of ISPE guidelines, FDA and EU regulation relating to steam sterilization and clean utilities
  • Experience of working in cross-functional, multi-disciplinary teams
  • Must be a good team player, willing to accept responsibility and accountability, willing to adopt flexible work practices with an open and approachable personality.

 

Please Note

All CV’s are treated in the strictest confidence.
Recruitment agencies need not apply.

Submit an Application Now

Do you have what it takes ?

Project Engineer - Louth - DU19242 - DU19242

Louth, Ireland

Accepted formats are: Microsoft® Word and PDF files
Maximum 200 words allowed.