Validation Engineer - Cleaning Validation - Biotech - Dun Laoghaire - Dublin


Location: Ireland

EUR 50 - 65 Per Hour

Job Type: Contract

Industry: Biotech-Pharma-Medical-Device-Jobs

Job ID: JO-1908-19241

Consultant: Karen McHugh






Do you have circa 6+ years’ experience in cleaning validation with major Pharma and Biotech manufacturing companies implementing the strategies for cleaning cycle development including; cleaning verification, syringe filling and API manufacture?

If you have the relevant experience, please forward your CV to karen@jobcontax.com for review or call 353 1 7978720 to discuss in confidence.


Validation Engineer - Cleaning Validation - Biotech - Dun Laoghaire - 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

Development of Cleaning and Sterilisation Validation Strategy, Validation Plans, Protocols and Reports for all cleaning and sterilisation equipment and processes for a Sterile Fill Finish Facility. 

Ensure all aspects of Cleaning and Sterilisation Validation adhere to required policies and procedures, including safety and training. 

Load Configuration and cycle development Cleaning Validation and Performance Qualification. 

Ensure that the Site 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 for Autoclaves, CIP, Parts Washers and Ultrasonic Baths used to support Sterile Vial and Syringe Manufacturing. 

Handle biological indicators and perform thermal mapping executions with Ellab and LIVEs validation hardware 

Participate as required in project activities. 

Participate, when required, as a member of multidisciplinary site and multisite teams, e.g. Cross Functional Investigation Team. 

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. 

Develop and rollout Validation Training for the site on subjects assigned by the Site Validation Leader. 

Comply with the responsibilities as outlined in the Site Safety Statement and champion safe working practices and initiatives within their functional area 

Perform all tasks with due care and attention and in accordance with Good Manufacturing Practices and Amgen’s requirements, policies and procedures 


Requirements

Minimum 4+ years overall experience in a similar role. 

Cleaning and Sterilisation Experience essential (min 2 years) 

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

Candidates MUST have GMP experience in pharma/bio 

Component Preparation Commissioning Experience an advantage 

Problem solving ability and excellent oral and written communications skills 

Customer service 

Honesty and consistency 

Planning and prioritisation 

Drive for results 

Creative and analytical thinking 

Focus on quality 

Attention to detail


Package

Hourly Rate €50 - €65 per hour

Minimum contract duration: 12 months

Potential to work from home


Contact

Karen McHugh is the consultant managing this position.

If you have any queries about this role, you can contact him by e-mail karen@jobcontax.com or phone +353-1-7978720

TAGLife


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