Providing downstream purification technical support to 12K protein DS manufacturing facility to ensure plan of record and site objectives are met.Support major investigations, preparing process and product quality impact assessments.Provide technical oversight of routine process monitoring CPV and follow up on any adverse trends.Support the review and assessment of Supplier Change Notices and introduction of new raw materials.Implement process improvements ideas e.g. yield/robustness/cost reduction.Process validation execution of refiltration and lifetime studies.

Fully trained on 8 systems and responsible for executing all tasks associated with; Flow-through and Ion-exchange Chromatography, Initial and Final UF/DF(ultrafiltration/diafiltration), transfer out to BDS vessels and single use bags, Viral Inactivation and Viral filtration.Proficient in using manufacturing systems such as; PDOCs, Gnosis, LIMS, SAP, MES, QTS, Veeva Vault, AMPs and EAMs. Ensuring the safe completion of tasks in accordance with data integrity requirements of a cGMP environment. Working in a team and training new colleagues on process execution and equipment operation, product changeover, SOPs, batch records, both paper and electronic. Troubleshooting any processing or equipment issues that arise in a grade C/D manufacturing area.

Assisted in the raising and closing of events on Veeva Vault, by engaging with numerous different teams to identify the true root cause and impact assessment within business timelines.Implementing CAPAs through QTS action items, SOP redlines updates and raising CRFs for AMPS updates to prevent recurrences.Use of technical writing skills in order to route deviations to QA’s satisfaction.Attending IMEX meetings to give updates and escalate any issues that arise.

Supported the introduction of new products, by ensuring validation hold times were recorded in the relevant protocols, additional non-routine samples were taken and change controls were referenced.Completed training on major process changes and gave user feedback.Coordinating with personnel to ensure changeover tasks are completed such as; sampling, trace tagging of equipment and filling out of protocols. Participating in media and buffer trials needed for the introduction of new products. Experience in using a standard work model to ensure efficiency between areas.

Responsible for right first-time creation of SOP’s, batch records (electronic and paper) and protocols using various forms of electronic document management systems. Updating and reviewing documentation in response to CAPAs in order to improve manufacturing activities. Construction of changeover protocols to assist in the development of new and lean methods of moving efficiently from one product to another. Tasks included: Walking down each system to understand cleaning procedures and the handling of product contact equipment. Delivering a rollout on the execution of changeover tasks to technicians. Part of the risk assessment team for Closure Analysis Documentation, specific tasks included: Process mapping of Initial and Final UF/DF unit operations. Constructing documentation to assess the risk of microbial, environmental and viral contamination.