This is what you will do: The Bio-Process Technician is a member of a high performing, empowered shift team, responsible for executing production according to schedule using MCS automation, completing electronic batch records, SAP materials consumption, routine maintenance checks and continuous improvement of the work processes and environment.
You will be responsible for: Assist in maintaining a safe, cGMP compliant work environment at all timesPerform all core production tasks in the areas of cell culture, media preparation, purification, buffer preparation and all ancillary tasks such as equipment preparation.Develop and demonstrate individual specialisms as subject matter experts and are required to display technical leadership by acting as 'Champion' to drive improvements and excellence within specific aspects of the manufacturing operation within the shift team.Responsible for execution of all tasks associated with the preparation for and production of Alexion products in cGMP environment ensuring full attention to detail and excellent documentation skills.Responsible for completion of tasks according to SOPs and batch records (paper and electronic).Responsible for batch record review for closure, both paper and electronicPerform initial troubleshooting of issues identified during routine operations.Assist with the investigation of and operations deviations through the Quality Management System, engaging with all relevant personnel and functions as appropriate.Assist where necessary with the training of colleagues in SOPs, process execution and equipment operation.Provide input into the creation and maintenance of area SOPs and batch records.Seek and implement opportunities for Continuous Improvement.Use Lean Tools as part of daily operations (Standard Work, 5S, Tier Meetings etc.)
to optimize efficiency and drive the culture of Continuous Improvement and Zero DefectsWhere necessary assist in any in Facility and Equipment start up and Validation activities.
Provide input on equipment installation, start-up, operation and troubleshooting to support introduction of new products into sustaining operations.Extended day shift working is required.
The shift pattern may be varied according to business requirements and will require weekend working.You will need to have: 3+ years' external experience in a cGMP biotech or closely allied pharmaceutical manufacturing environmentMust be able to work within and adapt to complex electronic systems such process automation, SAP and Trackwise investigation system.Must have in-depth knowledge of biotech manufacturing processes and their translation into documentation such as batch records and SOPsMust be familiar with biopharmaceutical equipment and systems such as bioreactors, centrifuges, autoclaves / glass washers, media/buffer systems, and purification systems such as UFDF and Chromatography ColumnsKnowledgeable of current Good Manufacturing Practices (cGMPs) and regulatory requirements.Must possess strong verbal and written communication skillsWe would prefer for you to have: BA/BS in a scientific discipline or equivalent experience preferred.Inoculum Laboratory experience and Chromatography Column packing experience would be beneficialExperience in deviation writing and CAPA creation with EQV and TrackWise systemsAstraZeneca 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.
#J-18808-Ljbffr