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 solutions

You 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 environment

We would prefer for you to have:

BA/BSc in a scientific discipline or equivalent experience.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.