Auto req 13867BR
Job Posting Title Sr Packaging Validation Engineer
Career Category Engineering
Employee Subgroup Salaried FT
Country (State/Region) Ireland
Location (City) Dublin
Dun Laoghaire
Amgen Job Description Job Title Senior Packaging Validation Engineer
Job Description Senior Packaging Validation Engineer
As a senior Packaging validation engineer, you will be responsible Leading a Cross Functional Team to ensure that the Validation Activities associated with the Packaging and Labelling and Shipping of Sterile Filled Syringes and Vials 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 Vial and Syringe Packaging for a large scale packaging operations.
• Leading the team to ensure all aspects of activity within the Packaging 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.
• 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.
• Participate as required in project activities.
• 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 5-10 years experience in a similar role.
Preferred Qualifications Overall knowledge in equipment, facility, cleaning and steaming validation. Technical understanding of pharmaceutical/biotechnology unit operations. Project management skills Skilled at initiation and leading cross functional teams Database and spreadsheet application skills Strong technical writing and oral communication skills Facilitation and presentation skills Experience with leading complex investigations and CAPAs Ability to evaluate compliance issues and interact with regulatory inspectors
