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Ref: 091216PEngCC

Project Engineer

  • Cork city
  • 50000 - 60000
  • Permanent full-time
  • Updated 17/02/2017
  • Brid Gallagher
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Description

Project Engineer required for a manufacturing environment based in Cork. Engineering qualification with previous experience of working within a GMP environment.

 

The successful candidates will plan, design, coordinate, validate and implement high technology equipment and/or processes for the site. He/she will also provide engineering support to ensure high yields and minimize downtime of process equipment prior to implementation into production.
Responsibilities
  • Responsible for introducing and validating new equipment and/or complex new process projects from design through completion and in compliance with regulatory requirements.
  • Responsible for project management & planning and for liaising with other departments affected by these projects. Also for reporting project status to management and highlighting areas of concern early.
  • Responsible for ensuring all projects are completed to agreed timelines and within budget.
  • Responsible for planning and managing equipment implementation to ensure effective utilization of multi departmental resources both internal and external to the company.
  • Assigned work adheres to EHSE requirements.
  • Ensure continual Quality System compliance by adherence to established Client requirements
  • Author and/or review and approval of protocols, technical reports, SOPs, and technical specifications. Compilation of technical documentation for regulatory submissions.
  • Responsible for applying cost improvement and LEAN Manufacturing initiatives in projects.
  • Responsible for optimising new processes through process analysis and the application of engineering principles.
  • Manages assignments / project works performed by outside vendors
  • Provide Support to the engineering department when required.
Requirements:
  • Knowledge of process engineering, equipment, automation specification and GMP validation requirements.
  • Bachelor's degree in Process; Chemical; Mechanical; Electrical Engineering or other related discipline.
  • Project Management Qualification desirable
  • Experience of current cGMP requirement of an FDA/HPRA approved facility
  • PC and software proficiency - Microsoft software and Microsoft project
  • 3-5 years + experience in API Production environment with experience of process engineering and equipment validation.

ESS Ltd.

ESS Ltd.

 

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