Auto req 13863BR
Job Posting Title Sterile Filling & Inspection Validation Engineer
Career Category Engineering
Employee Subgroup Salaried FT
Country (State/Region) Ireland
Location (City) Dublin
Dun Laoghaire
Amgen Job Description Job Title Sterile Filling and Inspection Validation Engineer
Job Description Sterile Filling and Inspection Validation Engineer
As a Sterile Filling and Inspction validation engineer, you will be responsible Leading a Cross Functional Team to ensure that the Validation Activities associated with the Sterile Syringe Filling and Inspection for a Sterile Manufacturing Facility are in compliance with Division Quality System requirements and recognised international standards.
Major Responsibilities
• Development of Validation Plans, Installation Verification, Functional Testing and Performance Qualifications (PQs) for Sterile Syringe Filling, Isolator and Inspection for a Sterile Fill Finish Facility.
• Ensure all aspects of Syringe Filling, Isolator and Inspection Validation 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.
• Pre-approve and post-approve validation protocols and assessments from a quality system documentation perspective for Syringe Filling, Isolator and Inspection Systems.
• Participate as required in project activities.
• Liaise with Engineering and external vendors regarding equipment User Requirement Specifications (URS’s), Factory Acceptance Tests (Fat’s) to ensure the QBD principles are being followed.
• 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.
Basic Qualifications Experience/Background
• A third level qualification in Science, Engineering or a relevant Quality discipline.
Syringe Filling and Isolator Technology Experience essential
Automated Inspection Technology Experience an advantage
• Minimum 4-6 years experience in a similar role.
Education Requirements
• A third level qualification in Science, Engineering or a relevant Quality discipline.
