Are you a Senior Valiidation Engineer with experience in Biotech/Pharma? Would you like to work for Amgen, a company who provides an outstanding work environment and opportunities for career development? If you have what it takes, send your CV to karen@jobcontax.com or call (01)7978720 for a confidential chat.
Senior Validation Engineer - Sterility Isolator - 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
As a Sterility Isolator Validation engineer, you will be responsible for ensuring that the new sterility isolator in the lab and the Validation Activities associated with the isolator are in compliance with Division Quality System requirements and recognised international standards.
Major Responsibilities
Development of Sterility Test Isolator Validation Strategy, Validation Plans, Protocols and Reports
Ensure all aspects of Sterility Test Isolator Validation adhere to required policies and procedures, including safety and training.
Load Configuration and cycle development Sterility Test Isolator Validation and Performance Qualification.
Ensure that the isolator meets the quality requirements of its customers and applicable regulations FDA, EU & International Standards.
Pre-approve and post-approve vendor protocols and assessments from a quality system documentation perspective Sterility Test Isolator
Liaise with Engineering and external vendors as required
Assist in the development of any existing Validation program to ensure continued compliance to the necessary regulations. Input to Site Validation Guidance Documents
Collate and report on relevant Validation data/matrices.
Assist in deviation and exception resolution and root cause analysis.
Requirements:
A third level qualification in Science, Engineering or a relevant Quality discipline.
Isolator or Sterilisation Experience essential
Minimum 4-6 years experience in a similar role.
A third level qualification in Science, Engineering or a relevant Quality discipline
Package:
Minimum 6 month contract
Rate €45 - €60 per hour
Contact:
Karen McHugh is the consultant managing this position. If you have any queries about this role, you can contact Karen by e-mail karen@jobcontax.com or phone +353-1-7978720
Click to connect with Karen on LinkedIn
Similar Jobs
Amgen Jobs in Ireland
Jobs in Dublin
Validation
Are you a Senior Valiidation Engineer with experience in Biotech/Pharma? Would you like to work for Amgen, a company who provides an outstanding work environment and opportunities for career development? If you have what it takes, send your CV to karen@jobcontax.com or call (01)7978720 for a confidential chat.
Senior Validation Engineer - Sterility Isolator - 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
As a Sterility Isolator Validation engineer, you will be responsible for ensuring that the new sterility isolator in the lab and the Validation Activities associated with the isolator are in compliance with Division Quality System requirements and recognised international standards.
Major Responsibilities
Development of Sterility Test Isolator Validation Strategy, Validation Plans, Protocols and Reports
Ensure all aspects of Sterility Test Isolator Validation adhere to required policies and procedures, including safety and training.
Load Configuration and cycle development Sterility Test Isolator Validation and Performance Qualification.
Ensure that the isolator meets the quality requirements of its customers and applicable regulations FDA, EU & International Standards.
Pre-approve and post-approve vendor protocols and assessments from a quality system documentation perspective Sterility Test Isolator
Liaise with Engineering and external vendors as required
Assist in the development of any existing Validation program to ensure continued compliance to the necessary regulations. Input to Site Validation Guidance Documents
Collate and report on relevant Validation data/matrices.
Assist in deviation and exception resolution and root cause analysis.
Requirements:
A third level qualification in Science, Engineering or a relevant Quality discipline.
Isolator or Sterilisation Experience essential
Minimum 4-6 years experience in a similar role.
A third level qualification in Science, Engineering or a relevant Quality discipline
Package:
Minimum 6 month contract
Rate €45 - €60 per hour
Contact:
Karen McHugh is the consultant managing this position. If you have any queries about this role, you can contact Karen by e-mail karen@jobcontax.com or phone +353-1-7978720
Click to connect with Karen on LinkedIn
Similar Jobs
Amgen Jobs in Ireland
Jobs in Dublin
Validation
We need : English (Good)
Type: Permanent
Payment: package
Category: Pharmaceutical