You are visiting this website from:
View All Jobs

Project Engineer (Validation) - Cork

Job Seekers Ireland Engineering Life Science

Job Summary

  • Cork
  • Permanent
  • BBBH764242
  • Aug 26, 2020
  • €40k - €50k
Job Description

Project Engineer (Validation) - Medical Devices

The Role

The role requires technical ownership to be taken for several process steps and contributing towards key business drivers such as drafting of documentation and Execute validations on new equipment introductions / processes / process changes. Examples include URS development / IQ / OQ / PQ + PV / Validation Plans / Risk Assessments / PFMEA / Test Methods

The successful candidate will be responsible for working as a liaison to external suppliers regarding contracted products, tools & fixtures and their manufacture as well as acting as a technical expert or complete special projects in individual areas of expertise

Responsibilities

  • Process development including PFMEA and Process Characterisation through engineering studies.
  • Planning & execution of key deliverables & action plans with the help of the Project Manager
  • Regular reporting on the status, performance and risks of your projects.
  • Work in cross-functional project teams in order to accomplish new product implementation, process design, process improvement or any other technical manufacturing issues
  • Provide technical guidance during project design and implementation, including Commissioning & Process Qualification, to assure viability of technology in proposed configuration
  • Identify and lead cost and technical improvements under the customer's continuous improvement programs.
  • Provide technical / process knowledge in cleaning & packaging within a regulated industry.
  • Understanding of the requirements around sanitization and sterilization processes.
  • Understanding of Validation and Computer Systems Validation

Requirements

  • Third level degree in Engineering or similar discipline.
  • Good 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
  • Experience in regulated industry, FDA, ISO, etc for Medical Devices/Pharma
  • Knowledge of Clean lines and Non-Destructive Testing Methods would be advantageous

Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.

BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.

Consultant Details

Consultant Details

john-murphy
John Murphy
  • Consultant
  • 353 (0) 21 2300300
  • johnmurphy@morganmckinley.com