Senior Validation Engineer

SIGMAR RECRUITMENT

MAYO

Senior Validation Engineer. The Validation Department is responsible for the qualification / validation of all CGMP equipment, systems and processes utilized for routine operation at the manufacturing site. The Department is also responsible for the revalidation of critical systems & processes. Responsibilities: You will provide technical oversight and guidance to other validation engineers and Business Units in the relevant subject matters and oversee related validation associated with these. You will also facilitate the coordination of the Revalidation Schedule on BMRAM, ensuring all activities are completed within the required time-frame. You will also assist the Validation Manager in other areas such as training, maintaining department metrics, coordination of the laboratory validation documentation review schedule, coordination of the APR schedule and assisting in Audit preparation or responses. Over-see, Coordinate, guide and implement the site validation master plan under prospective and concurrent validation studies in a timely manner, with the relevant engineers. Ensure that all validation requirements are met for any new process, equipment or change to existing processes or equipment. Manage the Revalidation schedule across the relevant Business Unit including co-ordination with System Owners and Laboratories for testing. Review and approve associated revalidation documentation. You will actively lead validation projects, being the departmental point person and completing all associated project documentation in line with current corporate and regulator expectations. Education and Experience: Bachelor’s degree required in science based or engineering discipline. Minimum 4 years experience in the area of validation / similar role. Excellent project management skills. Ability to articulate clearly when dealing with internal and external bodies. Excellent conflict handling skills. Expertise in the relevant subject matter areas – example cleaning, CSV, Aseptics, process, CPV, Facility etc. For more information, please contact Emma on 086 780 8679. Note, this business is still operating as normal with the correct social distancing and safety measures in place. Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.

1423 days ago