Snr Cleaning Validation Engineer
- Dublin
- Contract
- Full-time
- 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 client 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
professionals for organisations throughout Ireland; for more information go to www.berkley-group.comIf you would like to discuss this vacancy further or to discuss your career options in confidence, please contact David O'Connell on +353 86 1263871 or send your CV to doconnell@berkley-group.com.