Commissioning and Validation Engineer

Job type:
on-site
Start:
n.a
Duration:
n.a
From:
Quanta Consultancy Services
Place:
Ireland
Date:
03/09/2016
Country:
flag_no Ireland
project ID:
1087793

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An experienced Commissioning and Validation Engineer is required to join a Pharmaceutical organisation based in Ireland. This is a role that will require the successful engineer to work 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.  



Duties and 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 and Skills Required:



• Equipment and Systems Qualification experience up to and including PQ.

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

• Experience of working in a similar role.



 To learn more about this excellent and rare opportunity to join a prestigious Global Pharmaceutical organisation and fulfil a unique and rewarding role, please send in your current CV