Cleaning Validation Engineer

• This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
• There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
• Our client is developing the capability to produce all its medicines in Dublin, helping to ensure continuity of supply of our medicines as they expand internationally.

• Development of Cleaning 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 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 CIP, COP, Parts Washers and Ultrasonic Baths used to support Sterile Vial and Syringe Manufacturing.
• Take swabs and rinse samples and perform laboratory studies to support cleaning validation studies on site.
• 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.
• Perform all tasks with due care and attention and in accordance with Good Manufacturing Practices and company requirements, policies and procedures.

• A third level qualification in Science, Engineering or a relevant Quality discipline.
• Cleaning Validation Experience essential: Minimum 4-6 years experience in Cleaning Validation.
• Cleanroom Experience an advantage.
• Problem solving ability and excellent oral and written communications skills.
• Customer service.
• Planning and prioritisation.
• Creative and analytical thinking.
• Focus on quality.
• Attention to detail.

Team Horizon