Cleaning Validation Engineer

Team Horizon is seeking a Validation Engineer for a leading pharmaceutical company in South Dublin

As a Cleaning validation engineer, you will be responsible for ensuring that the Cleaning Validation Activities associated with the Sterile Vial and Syringe Manufacturing Facility are in compliance with Division Quality System requirements and recognized international standards.

Why you should apply:

• 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.

What you will be doing:

• 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.

What you need to apply:

• 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.