Fill Finish Validation Lead - DublinAre you a Fill Finish Validation Leadwith 7+ years experience of sterile / biotech equipment validation within the pharmaceutical industries?This is a contract role based in Dun Laoghaire, Dublin.Our client is a leading international Biotechnology company with a state of the art aseptic manufacturing facility in Dun Laoghaire, South Dublin.
The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment.
This is an excellent opportunity to get experience into Ireland's leading aseptic manufacturing plant.Validation lead for a large-scale Fill Finish Project in the Pharmaceutical Industry.
Lead a team of Validation engineers to ensure the Validation activities associated with a large fill finish project are completed safely, as per schedule and in compliance with GMP and Quality Requirements.
Coordinates and Supervises all Validation activitiesApproves Validation planning documents detailing overall strategy for the project.Develops and approves the master list of Validation test documents and activities.Reviews and Approves all C&Q summary reports and Validation Summary reports.Ensures the Validation schedule is developed and maintained.Ensures all Validation Engineers who perform Validation activities have relevant training assigned.Pre-Approval and Post approval of Validation test documents.Manages Validation coordination meetings.Responsible for Overall Tracking and Reporting of Validation status and risks/issues.Assist in the development of User Requirement Specifications (URS's) and Quality Risk Assessment for Equipment and Automated Systems (QRAES)RequirementsBS degree with 7+ years of experience in Validation, Engineering, Microbiology or QualityExtensive knowledge and demonstrated experience managing Validation activities for Pharmaceutical / Biotechnology projectsExperience of sterile / biotech equipment within the pharmaceutical industry is preferred.Demonstrated strong Communication and Leadership skills.Demonstrated ability to collaborate with senior stakeholders to achieve optimal outcomes.Strong understanding of a risk-based approach to commissioning, qualification and validation within the biotechnology industry In-depth understanding and application of validation principles, concepts, practices, and standards.In-depth knowledge with cGxP as well as regulatory regulations and compliance requirements for Biologics Drug Product manufacturingWorking knowledge of sterilization/decontamination systems and industry practices.Experience with AVS (Airflow Visualization) Studies.Experience of aseptic processingExtensive knowledge and demonstrated experience managing Validation activities for Pharmaceutical / Biotechnology projectsExperience of sterile / biotech equipment within the pharmaceutical industry is preferredExperience in GMPPackageContract role - Hourly rate €55 - €65 per hourMinimum 12 month contract with the possibility of an extension.
Onsite Expectations: 5 days per week.
These projects require the Validation Lead to be onsite, once the projects are at certain stages there will be opportunities throughout to do some hybrid work.
