Job Details: Senior Validation Engineer


jobContax

104 Upper Drumcondra Road,
Dublin 9
http://www.jobcontax.com
Please contact: Karen
JobContax was founded in 2001 by Karen McHugh, an engineer passionate about offering quality opportunities to the jobseeker and an intelligent service to the client. Jobcontax has successfully operated as a global market leader and technical specialist within the following sectors:

Construction and Infrastructure

Engineering and Design

Mining - Oil and Gas

Biotechnology and Pharmaceutical

During the past 10 years Jobcontax have expanded our international network across 5 continents. In 2005 we began recruiting for the Australian market and in 2011 we set up our first strategic partnership in WA. In March 2010, we opened our Shanghai office to strengthen our presence in the rapidly expanding Chinese market for highly skilled professionals. JobContax has a strong presence in Canada, Europe and the Middle East.

Jobcontax has built its reputation on its consultative approach. Our understanding of the industries and the businesses and individuals within these industries enables us to facilitate the perfect match between client and jobseeker. From global multinationals to SME?, Jobcontax has become the trusted recruitment partner.
Senior Validation Engineer


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

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