Lengnau, Berne, Switzerland
Provided support and troubleshooting in Drug Substance Manufacturing areas like USP, DSP, and Solution Preparation (MBP). Ensured quality, safety, and compliance by reviewing exceptions, supporting batch record reviews, and leading deviation investigations and CAPAs Represented operations in facility design, tech transfer, commissioning, and validation of new production lines Drive continuous quality and process improvements using Practical Process Improvement (PPI) methodologies Collaborated with various departments and represent DS Manufacturing in external interactions
CQV field execution and support role for expansion project at Peptide/API production facility. Part of Environmental, Health and Safety (EHS) team responsible for safety checks in the field, issuing of work permits and execution of LOTO (Lock Out-Tag Out) for control of hazardous energy.
Close out of qualification documents for filling line process equipment. Lead CQV engineer for introduction of automated bottle filling machine as part of NSYNC Modue B at Lonza. Resolution of outstanding punch items from filler and isolator SAT. Management and organization of vendors to carry out qualification works on RABS isolator and filling machine. Resolution of deviations that arose during the qualification process, and management of equipment vendor to carry out corrective actions. Acted as main technical SME and point of contact for equipment at Lonza. Worked with Operations and QA departments to resolve any issues and queries with approval of qualification documents. Lead the handover effort for new equipment, answering technical questions from other engineers within my team and driving deliverables to completion.
Commissioning of Large Scale Bioreactors (LSBR) as part of BMC2 qualification. Used Delta V platform to run feed and inoculation transfers, SIP, pressure control and other commissioning tests on large bioreactors. Use of Kneat software to document results of commissioning and qualification activities. Resolution of issues observed during commissioning. Qualification of feed vessels and bioreactors following closeout of commissioning. Qualification of buffer preparation and hold vessels, carrying out execution of WFI batching, pressure control, transfer and interlock testing of vessels . Work with quality and validation departments to drive completed qualification protocols to final approval. Training of manufacturing associates on operation of process equipment and resolution of issues arising during equipment operation.
MC Package Owner for downstream process equipment Qualification of temperature controlled units including fridges, freezers and incubators. CQV System Owner for multiple pieces of process and analytical equipment in innoculation and cell banking areas. Authoring of IQ and OQ wraps and associated documentation. Supervision of Vendors on site to carry out qualification works. Setup, commissioning and qualification of in equipment supporting downstream and upstream processing. Working with various stakeholders to resolve issues in qualification as they arise.