This is what you will do:Our Manufacturing Team provides manufacturing support to complex life changing biological products.
Support new product introductions, process monitoring, investigations, changes, improvement projects, technical training, operational excellence and documentation.
The team provides a key interface between the shift operations teams and day-based multi-functional support.
Manufacturing Technologists provide key timely front line Operations technical support to the BDS processes during all phases of facility and product start up and into ongoing commercial supply.The main area of responsibility of this role is the technical ownership of upstream / downstream unit operations and provide real time technical leadership on any process or equipment issues in line with business strategies and objectives.This specialist is also responsible for the successful execution of projects and improvements identified as point of the Dublin facility priority list.
These are in several categories, including: new process / equipment introduction/remediation/optimisation (CAPEX & OPEX), process innovation, automation, product transfers, process feature optimisation & improvements, new material introduction, equipment qualification, continuous improvement /cost reduction in facility and process operationYou will be responsible for:Build, mentor and sustain employee engagement by crafting a culture of efficient execution and improvement in which individuals and teams can excel.Leader and provider of guide technical and documentation support to investigations, CAPA's, change controls, training and improvement projects ensure the manufacture of bulk drug substance is performed in a safe, compliant, cost effective manner meeting the regulatory requirements defined in relevant health authority submissions, cGMPs and Health and Safety requirements.Providing end user operations requirements input into design, commissioning and validation of equipment, automation and processes as segment of multi-function project teams.Taking a lead role developing Operations procedures, batch records (electronic or paper as required), documentation and provide technical training to the Operations teams.Taking an active role in setting up work practices and procedures that minimize human error, and work with operations continuous improvement teams to remove sources of error.Leading teams to deliver all project requirements associated with cost, time and functionality, ensuring that all KPI targets are achieved.Development and maintain effective relationships with partners at College Park including Quality, Engineering, Technical Services, Supply Chain, Regulatory Affairs, Human Resources and Finance.
They lead and contribute to best practice sharing with manufacturing and technical colleagues at other Alexion facilities and across the industry.You will need to have:Experience in Manufacturing Operations, Technical Support or Equipment Engineering in a biopharmaceutical company or closely aligned industry (working in an GMP environment).Extensive knowledge of a biological manufacturing processesWell-developed analytical, numerical and digital literacy and the ability to combine hands-on activities with theoretical knowledge and expertise.Strong problem solving and troubleshooting capabilityGood Presenting and Training SkillsGood Technical writing skillsExcellent communications and decision-making skillsConfirmed ability to work well as part of a team & on own with minimum supervisionValidated mentorship skills.Green Belt in Lean six sigma an advantageWe would prefer for you to have:Experience with leading projects in areas such as media prep, buffer prep, sterile filtration, upstream and downstream unit operations.Experience of formulation, aseptic and sterile manufacturing, including, autoclaves, sterile filtration, Vial and Syringe packaging would be an added advantage.Experience in investigating complex manufacturing investigations, CAPA's and Change Controls.Good knowledge of GMP/HPRA/FDA regulatory requirements Laws.Green Belt in Lean six sigma an advantage.Date Posted21-Aug-2024Closing Date03-Sep-2024Our mission is to build an inclusive and equitable environment.
We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process.
We welcome and consider applications from all qualified candidates, regardless of characteristics.
We offer reasonable adjustments/accommodations to help all candidates to perform at their best.
If you have a need for any adjustments/accommodations, please complete the section in the application form.
