Commissioning & Validation Engineer

Job type:
on-site
Start:
04/2016
Duration:
8 months
From:
Real Staffing
Place:
Republic of Ireland
Date:
03/18/2016
Country:
flag_no Ireland
project ID:
1094025

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We are currently working with a World leader in Bio pharmaceuticals who are looking to bring in a Commissioning & Validation Engineer on an 8 month contract in April. As a Commissioning & Validation Engineer you will be responsible for working within a cross functional team to ensure that the validation activities associated with process equipment for vial and syringe fill finish processes meets system requirements and recognised international standards.

Main Responsibilities

- Assist in development of Validation plans and development of Installation Verification, Functional testing and performance Qualifications (PQs) for equipment.

- Working with the team to ensure all aspects of activity within the commissioning and Validation of equipment adhere to required policies and procedures, including safety and training.

- Ensure that the site meets the quality requirements of its customers and applicable regulations FDA, EU & International Standards.

- Prepare and execute Validation protocols and can complete risk assessments from a quality system perspective.

- Assist with engineering and external vendors regarding equipment user requirement specifications (URS's), DQ

- Assist in the implementation of any existing Validation program to ensure continued compliance to the necessary regulations.

- Assist in Deviation and exception resolution and root cause analysis

- Participate as required in project activities

Experience/Background

- Equipment & System qualification experience up to and including PQ

- A third level qualification in Science, Engineering or a relevant Quality discipline.

- Minimum 5 years experience in a similar role.

For more information and the full Job Spec please contact Jamie McLaren on

To find out more about Real please visit www.realstaffing.com

Real Staffing, a trading division of SThree Partnership LLP | Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales