Job Title: Cleaning and Sterilisation Validation Engineer
Overview of Role:
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
• Perform all tasks with due care and attention and in accordance with Good Manufacturing Practices and Amgen’s requirements, policies and procedures
• A third level qualification in Science, Engineering or a relevant Quality discipline.
• Cleaning and Sterilisation Experience essential (min 2 years)
Candidates MUST have GMP experience in pharma/bio
• Component Preparation Commissioning Experience an advantage
• Problem solving ability and excellent oral and written communications skills
• Minimum 4-6 years overall experience in a similar role.
For additional information or to submit your CV get in touch with Sarah : email@example.com