Trained and mentored new trainees on best practices, developing them to be effective technicians and SMEs.Identified and addressed compliance, environmental, safety, and process deviations, notifying appropriate personnel.Performed sampling/in-process testing to support the manufacturing and validation process for current processes as well as development work for new products and processes as required.Performed an array of key duties including real time batch record… Show more Trained and mentored new trainees on best practices, developing them to be effective technicians and SMEs.Identified and addressed compliance, environmental, safety, and process deviations, notifying appropriate personnel.Performed sampling/in-process testing to support the manufacturing and validation process for current processes as well as development work for new products and processes as required.Performed an array of key duties including real time batch record review, aseptic observer walk throughs, RT report review prior to final approval, manual and automated operations, and general maintenance.Supported operations production by playing a key part in the startup, commissioning, and qualification process. Show less

Served as the SME within the Thaw/Pool/Fill suite, responsible for maintaining equipment and cleaning processing suites as required per SOP.Contributed to the culture of safety and quality through performing trouble shooting, cross departmental communication to ensure equipment/component readiness, and consistently participating in walk throughs.Developed a high level of proficiency with GLIMS, SAP, Delta V, and MES systems, among others.Performed can drops in grade A… Show more Served as the SME within the Thaw/Pool/Fill suite, responsible for maintaining equipment and cleaning processing suites as required per SOP.Contributed to the culture of safety and quality through performing trouble shooting, cross departmental communication to ensure equipment/component readiness, and consistently participating in walk throughs.Developed a high level of proficiency with GLIMS, SAP, Delta V, and MES systems, among others.Performed can drops in grade A sterile pooling suite and tested pre and post use filters associated with fill batch. Show less

Manufactured cell culture products per batch records in compliance with quality standards, company policies and current regulations.Oversaw aseptic processing in a cleanroom environment by using correct cleanroom behaviors, proper gowning and cleaning procedures.Ensured all items are issued and accounted for during execution of the batch record, monitoring critical parameters during cell growth.Responsible for sample submission to sample coordination lab and harvesting… Show more Manufactured cell culture products per batch records in compliance with quality standards, company policies and current regulations.Oversaw aseptic processing in a cleanroom environment by using correct cleanroom behaviors, proper gowning and cleaning procedures.Ensured all items are issued and accounted for during execution of the batch record, monitoring critical parameters during cell growth.Responsible for sample submission to sample coordination lab and harvesting the final product through filter pods.Documented each task involving manufacturing procedures following GDP at the time of execution in addition to utilizing and performing maintenance on equipment per applicable SOP. Show less

Instrumental in the manufacturing process, operating and cleaning coating equipment according to batch records and SOP’s, reconciling batches after each run, and documenting batch processing information.Showcased leadership capabilities through setting standards for high-quality, improved efficiency, and high-yield production, assisting in the training and development of new operating associates on best demonstrated practices.Assisted engineering by problem solving to resolve… Show more Instrumental in the manufacturing process, operating and cleaning coating equipment according to batch records and SOP’s, reconciling batches after each run, and documenting batch processing information.Showcased leadership capabilities through setting standards for high-quality, improved efficiency, and high-yield production, assisting in the training and development of new operating associates on best demonstrated practices.Assisted engineering by problem solving to resolve mechanical, process, and safety issues, resulting in manufacturing equipment, quality, and line performance improvements.Followed TSKF SOPs, filling in batch record and other quality documents according to data integrity requirements. Show less

Performed coating, compressing, and blending duties in a dedicated manufacturing suite; setting up, cleaning, and adjusting equipment as needed per SOP including disassembly and installation of all equipment and parts.Utilized eye for detail when monitoring processes and examining product and components to ensure specification requirements are met, performing tablet printing and reconciliation duties as well.Kept detailed, accurate and legible records of production activities… Show more Performed coating, compressing, and blending duties in a dedicated manufacturing suite; setting up, cleaning, and adjusting equipment as needed per SOP including disassembly and installation of all equipment and parts.Utilized eye for detail when monitoring processes and examining product and components to ensure specification requirements are met, performing tablet printing and reconciliation duties as well.Kept detailed, accurate and legible records of production activities following DSM/GMP guidelines.Conducted work order reconciliations and in-process quality checks as required. Show less