Description
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