We’re currently recruiting for an exciting opportunity with an award winning Pharmaceutical organization based in Dublin. This is an excellent opening for anyone who is looking to join a leading multinational who are one of the best at what they do.
As a Cleaning and Sterilisation validation engineer, you will be responsible for ensuring that the Cleaning and Sterilisation Validation Activities associated with the Sterile Vial and Syringe Manufacturing Facility are in compliance with Division Quality System requirements and recognised international standards.
• Development of Cleaning and Sterilisation Validation Strategy, Validation Plans, Protocols and Reports for all cleaning and sterilisation equipment and processes for a Sterile Fill Finish Facility.
• Ensure all aspects of Cleaning and Sterilisation Validation adhere to required policies and procedures, including safety and training.
• Load Configuration and cycle development Cleaning Validation and Performance Qualification.
• Ensure that the Site meets the quality requirements of its customers and applicable regulations FDA, EU & International Standards.
• Pre-approve and post-approve vendor protocols and assessments from a quality system documentation perspective for Autoclaves, CIP, Parts Washers and Ultrasonic Baths used to support Sterile Vial and Syringe Manufacturing.
• Handle biological indicators and perform thermal mapping executions with Ellab and LIVEs validation hardware
• Participate as required in project activities.
• Participate, when required, as a member of multidisciplinary site and multisite teams, e.g. Cross Functional Investigation Team.
• 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.
• Comply with the responsibilities as outlined in the Site Safety Statement and champion safe working practices and initiatives within their functional area
• A third level qualification in Science, Engineering or a relevant Quality discipline.
• Cleaning and Sterilisation Experience essential
• Component Preparation Commissioning Experience an advantage
If you would like further Information you can contact the recruiter directly:
Sean McCarthy | Tel: +353 (0) 87 798 8480