Auto req 13864BR
Job Posting Title HVAC & Utilities Validation Engineer
Career Category Engineering
Employee Subgroup Salaried FT
Country (State/Region) Ireland
Location (City) Dublin
Dun Laoghaire
Amgen Job Description Job Title HVAC/Utilities Validation Engineer
Job Description HVAC/Utilities Validation Engineer
As a HVAC/Utilities validation engineer, you will be responsible Leading a Cross Functional Team to ensure that the Validation Activities associated with the HVAC/Utilities 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 HVAC and Utilities for a Sterile Fill Finish Facility.
• Ensure all aspects of HVAC/Clean Utility 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.
• Be involved in all Validation Cross Functional Teams (CFTs) at the site to ensure adherence to required policies and procedures.
• Pre-approve and post-approve validation protocols and assessments from a quality system documentation perspective for HVAC, Clean Steam, Process Air and WFI Systems.
• Participate as required in project activities.
• Review of Existing Site Systems to ensure compliance.
• 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.
• Ensure all relevant employees are aware of corporate and relevant International Standards and their implementation throughout the plant.
Basic Qualifications Experience/Background
• A third level qualification in Science, Engineering or a relevant Quality discipline.
• Minimum 4-6 years experience in a similar role.
Education Requirements
• A third level qualification in Science, Engineering or a relevant Quality discipline.
