This is what you will do:The Drug Product (DP) Manufacturing Associate will be a key member in supporting the execution of operational readiness at the Alexion Athlone Manufacturing Facility. The Manufacturing Associate will be an SME in a number of unit operations throughout the Fill Finish manufacturing process and will be responsible for execution of batch operations as per standard operating procedures under limited supervision.You will be responsible for:Operate manufacturing equipment and instrumentsComplete assigned tasks in a timely mannerConduct daily activities in an organized, efficient mannerPerform simple, routine, complex, and critical operationsTroubleshoot equipment issues, when necessaryEnsure process equipment is appropriately maintained for operationPerform and document operations in accordance with cGMP’sImplement equipment qualification protocols and validation protocolsRoutinely draft/ create and revise standard operating procedures, manufacturing batch records and other documents as requiredRecognize, initiate process deviations and perform deviation investigations and closureSupport continuous improvement initiatives by identifying areas needing improvement, recommending strategies for improvement, and implementing those strategies once approvedAdopt the Skills You'll Use Every Day at AlexionMaintain training compliance and train other staffCommunicate effectively, written and verbalEnsure a safe working environment for all staffPlan daily activities and schedule operationsInteract with other departmentsAseptic Filling with RABS in grade B backgroundCompounding / Formulation of productsSterile Filling of vials / syringes using IsolatorVisual Inspection of finished product.Cleaning and Sanitation of equipmentOperation of Parts washers and AutoclavesCIP /SIP of Vessels.Support regulatory auditsSupport all new product/process introductions on site.Perform data collection, compilation, and statistical analysisInteract with vendors and outside resourcesComplete assigned projectsBe the shift lead if required, providing instruction to the teamTroubleshoot and resolve operational problems during processingRepresent Manufacturing in cross functional initiatives and meetingsMonitor and evaluate process trends and recommend and implement continuous improvement strategies as appropriateHandle multiple projects independentlyPlan and implement complex changesPerform Environmental monitoring as required.Technical authority for entire area(s)Interact independently with regulatory agenciesDevelop and provide training on complex manufacturing processesPerform Manufacturing review and approval of critical documentsDevelop process validation protocolsMaintain good housekeeping and clean and sanitize classified areas as required.Analyze complex problems and resolve and implement solutionsYou will need to have:Able to work within and adapt to complex electronic systems such as SAP and EQVAble to read, write and converse in EnglishHave good working knowledge of MS Excel and WordAbility to work in an intense, fast-paced work environmentAbility to function, with guidance, in a rapidly changing environment while balancing multiple priorities simultaneouslyAbility to work independently and as part of a teamMore than 2 years’ experience in a cGMP biopharmaceutical manufacturing environmentWe would prefer for you to have:BA/BSc in a scientific discipline or equivalent experience.Date Posted20-Jan-2025Closing Date02-Feb-2025Our 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.