Employer
Our Client is Amgen and the role will be based in their Dun Laoghaire plant. The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment..
Job Description:
Autoclave Validation Engineer/Component Prep Validation Engineer
As a Sterilisation validation engineer, you will be responsible for ensuring that the Sterilisation Validation Activities associated with the Sterile Vial and Syringe Manufacturing Facility are in compliance with Division Quality System requirements and recognised international standards.
Responsibilities:
Ensure all aspects of Sterilisation Validation adhere to required policies and procedures, including safety and training.
Autoclave load Configuration cycle development and Performance Qualification.
Performing Thermal Mapping of Complex Autoclave Loads for use in aseptic manufacture of parenterals
? Generate, execute validation protocols for execution to demonstrate compliance to a standard suitable for review by FDA and IMB auditors
? Assist in deviation and exception resolution and root cause analysis.
? Collate and report on relevant Validation data/matrices and generate summary reports to document the results of the Validation studies
? Ensure that the Site meets the quality requirements of its customers and applicable regulations FDA, EU & International Standards.
? Participate as required in project activities.
? Assist in the development of any existing Validation program to ensure continued compliance to the necessary regulations.
Requirements:
? A third level qualification in Science, Engineering or a relevant Quality discipline.
? Autoclave Thermal Mapping Experience essential
? Other Component Preparation Commissioning Experience an advantage
? Minimum 2-4 years experience in a similar role.
? A third level qualification in Science, Engineering or a relevant Quality discipline.
Package:
6 month minimum contract
Rate: ?40 - 45 per hour
Contact
Karen McHugh is the consultant managing this position. If you have any queries about this role, you can conAutoclave Validation Engineer - Amgen - Dublin
Employer
Our Client is Amgen and the role will be based in their Dun Laoghaire plant. The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment..
Job Description:
Autoclave Validation Engineer/Component Prep Validation Engineer
As a Sterilisation validation engineer, you will be responsible for ensuring that the Sterilisation Validation Activities associated with the Sterile Vial and Syringe Manufacturing Facility are in compliance with Division Quality System requirements and recognised international standards.
Responsibilities:
Ensure all aspects of Sterilisation Validation adhere to required policies and procedures, including safety and training.
Autoclave load Configuration cycle development and Performance Qualification.
Performing Thermal Mapping of Complex Autoclave Loads for use in aseptic manufacture of parenterals
? Generate, execute validation protocols for execution to demonstrate compliance to a standard suitable for review by FDA and IMB auditors
? Assist in deviation and exception resolution and root cause analysis.
? Collate and report on relevant Validation data/matrices and generate summary reports to document the results of the Validation studies
? Ensure that the Site meets the quality requirements of its customers and applicable regulations FDA, EU & International Standards.
? Participate as required in project activities.
? Assist in the development of any existing Validation program to ensure continued compliance to the necessary regulations.
Requirements:
? A third level qualification in Science, Engineering or a relevant Quality discipline.
? Autoclave Thermal Mapping Experience essential
? Other Component Preparation Commissioning Experience an advantage
? Minimum 2-4 years experience in a similar role.
? A third level qualification in Science, Engineering or a relevant Quality discipline.
Package:
6 month minimum contract
Rate: ?40 - 45 per hour
Contact
Karen McHugh is the consultant managing this position. If you have any queries about this role, you can con
We need : English (Good)
Type: Permanent
Payment: package
Category: Pharmaceutical
