Are you an Cleaning Validation Engineer with experience on Pharmaceuticals or Biotechnology plants? 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.
Cleaning 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
As a Cleaning validation engineer, you will be responsible for ensuring that the Cleaning Validation Activities associated with the Sterile Vial and Syringe Manufacturing Facility are in compliance with Division Quality System requirements and recognised international standards.
Development of Cleaning Validation Strategy, Validation Plans, Protocols and Reports for all cleaning processes for a Sterile Fill Finish Facility.
Ensure all aspects of Cleaning Validation adhere to required policies and procedures, including safety and training.
Load Configuration and cycle development, Cleaning Verification and Cleaning Validation.
Ensure that the Site meets the quality requirements of its customers and applicable regulations FDA, EU & International Standards.
Generate and execute protocols and assessments from a quality system documentation perspective for CIP, Parts Washers and Ultrasonic Baths used to support Sterile Vial and Syringe Manufacturing.
Participate as required in project activities.
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.
Requirements:
A third level qualification in Science, Engineering or a relevant Quality discipline.
Extensive Parts, Equipment and Vessel Cleaning Experience essential
Experience in Time Pressure Filling CIP an advantage
Component Preparation Commissioning Experience an advantage
Minimum 2 years experience in a similar role.
Package:
Minimum 6 month 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 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
Are you an Cleaning Validation Engineer with experience on Pharmaceuticals or Biotechnology plants? 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.
Cleaning 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
As a Cleaning validation engineer, you will be responsible for ensuring that the Cleaning Validation Activities associated with the Sterile Vial and Syringe Manufacturing Facility are in compliance with Division Quality System requirements and recognised international standards.
Development of Cleaning Validation Strategy, Validation Plans, Protocols and Reports for all cleaning processes for a Sterile Fill Finish Facility.
Ensure all aspects of Cleaning Validation adhere to required policies and procedures, including safety and training.
Load Configuration and cycle development, Cleaning Verification and Cleaning Validation.
Ensure that the Site meets the quality requirements of its customers and applicable regulations FDA, EU & International Standards.
Generate and execute protocols and assessments from a quality system documentation perspective for CIP, Parts Washers and Ultrasonic Baths used to support Sterile Vial and Syringe Manufacturing.
Participate as required in project activities.
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.
Requirements:
A third level qualification in Science, Engineering or a relevant Quality discipline.
Extensive Parts, Equipment and Vessel Cleaning Experience essential
Experience in Time Pressure Filling CIP an advantage
Component Preparation Commissioning Experience an advantage
Minimum 2 years experience in a similar role.
Package:
Minimum 6 month 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 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
We need : English (Good)
Type: Permanent
Payment: package
Category: Pharmaceutical
