Are you a Senior Process validation engineer with experience in Biotech/Pharma/Medical Device industries? 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 Process 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 Senior Process validation engineer, you will be responsible working within a Cross Functional Team to ensure that the Process Validation Activities and Aseptic Process Simulations at the Sterile Manufacturing Site are in compliance with Division Quality System requirements and recognised international standards.
Development of Validation Plans, Process Qualifications (PQs), and Process Simulations (Media Fills) for Vial / Syringe Filling.
working with the team to ensure all aspects of activity within the Process development and Validation group adhere to required policies and procedures, including safety and training.
Ensure that the Site meets the quality requirements of its customers and applicable regulations FDA, EU & International Standards
Prepare, execute and Review validation protocols, reports, supporting data and assessments from a quality system documentation perspective.
Assist in the development of any existing Validation program and site procedures to ensure continued compliance to the necessary regulations.
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.
Participate as required in project activities.
Flexible working hours may be required to support project activities
Requirements:
A third level qualification in Microbiology, Bio-Technology, Science, Engineering or a relevant Quality discipline.
Minimum 5-10 years experience in a similar role.
Package:
Minimum 18 month contract
Rate €50 - €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 Jobs
Are you a Senior Process validation engineer with experience in Biotech/Pharma/Medical Device industries? 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 Process 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 Senior Process validation engineer, you will be responsible working within a Cross Functional Team to ensure that the Process Validation Activities and Aseptic Process Simulations at the Sterile Manufacturing Site are in compliance with Division Quality System requirements and recognised international standards.
Development of Validation Plans, Process Qualifications (PQs), and Process Simulations (Media Fills) for Vial / Syringe Filling.
working with the team to ensure all aspects of activity within the Process development and Validation group adhere to required policies and procedures, including safety and training.
Ensure that the Site meets the quality requirements of its customers and applicable regulations FDA, EU & International Standards
Prepare, execute and Review validation protocols, reports, supporting data and assessments from a quality system documentation perspective.
Assist in the development of any existing Validation program and site procedures to ensure continued compliance to the necessary regulations.
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.
Participate as required in project activities.
Flexible working hours may be required to support project activities
Requirements:
A third level qualification in Microbiology, Bio-Technology, Science, Engineering or a relevant Quality discipline.
Minimum 5-10 years experience in a similar role.
Package:
Minimum 18 month contract
Rate €50 - €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 Jobs
We need : English (Good)
Type: Permanent
Payment: package
Category: Pharmaceutical
