Amgen Sr Validation Engineer in Dun-Laoghaire-Rathdown, Ireland
The Validation department performs equipment, utility, cleaning, sterilization and process validation activities to ensure compliance with company procedures and industry standards in support of Operations and Quality Systems for Drug Product Manufacturing.
The activities of the Senior Validation Engineer are:
Development of Validation Plans, Process Qualifications (PQs) primarily for sterilisation systems supporting both Vial and Syringe Drug Product facilities while supporting the Site Validation Strategy.
Analyse validation results and compile data into reports for initial qualifications and re-qualifications.
Act as SME to ensure all aspects of activity within the 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
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.
Participate as required in project activities.
Ensure all relevant employees are aware of corporate and relevant International Standards and their implementation throughout the plant.
Provide technical support in validation to meet objectives of quality, output and cost in developing, trouble shooting, standardising and improving new and existing equipment.
Assure that all validation test procedures are in line with current technology, corporate and governmental regulations.
Ensure all relevant employees are aware of corporate and relevant International Standards and their implementation throughout the plant
Knowledge of cGMP's and other worldwide regulatory requirements.
Problem solving ability and excellent oral and written communications skills
A third level qualification in Science, Engineering or a relevant Quality discipline.
8+ years' experience in a similar role.
In depth experience qualifying SIP systems within the sterile manufacturing environment of drug product (Lyophilisers, Formulation Vessels, Filling Lines).
Autoclave PQ and RQ experience.
Previous regulatory experience with regard to representing the site validation program in addition to supporting NPI regulatory marketing applications.