• Project management including scheduling, resource allocation, and proposal and cost estimate generation• Engineered, developed, and validated CIP (Clean In Place) systems, COP (Clean Out of Place) systems, and manual cleaning processes• Performed engineering review of CIP systems including flowpath development, piping and instrumentation diagrams (P&ID) review, and equipment design review for cleanability and validatability • Drafted and executed installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ)• Executed cycle development and validation activities including hydraulic balancing, parameter development, bench scale cleanability studies, and total organic carbon (TOC) recovery studies • Assisted in cleaning validation program development• Cleaning development and validation protocol drafting, execution, and reporting• Deviation investigation and resolution including root cause analysis and CAPA implementation

Contributing member of the Manufacturing group focused on API purification and downstream processes. This position included developing innovative solutions when working with multi-product process trains and implementing new processes onto existing equipment. Responsibilities included:• Tech transfer and implementation of process scale-up into the manufacturing facilities including batch record and SOP drafting for cleaning and processing activities• Implementation of new process equipment and control systems • Authoring change control to implement new processes and methods onto existing and new equipment• Qualification and validation activities for equipment, process, and cleaning • Troubleshooting and optimization of current processes• Led training activities for new and optimized processes including cleaning• Deviation investigation and resolution including root cause analysis and CAPA implementation• Project leader for LEAN implementation in order to reduce product change over time• Assisted with cleaning program design and implementation

Contributing member of the Process Development group focused on production of biopharmaceutical immunotherapies based on heat killed yeast. Worked in many different capacities including process scale-up, qualification activities, and assay development and execution. Responsibilities included:• Process development and optimization of fermentation, filtration, and inactivation unit operations• Developed and executed experiments on pilot scale equipment• Assisted in development and implementation cleanroom cleaning and disinfection program, material transfer program, and gowning program including qualification and routine sampling program• Assisted with cleanroom design to implement process scale up in an EU and FDA compliant manner• Performed and assisted in development of analytical assays such as Western Blot, Total Protein, and HPLC• Assisted with process scale-up equipment design and specifications including URS, FRS and DDS drafting and review• Participated in vender audits and equipment acceptance tests (FAT and SAT)• Tech transfer and implementation of process scale-up into the manufacturing facilities including batch record and SOP drafting for processing activities• All processes were based on disposable technologies

Project manager for cleaning validation activities within biotech and pharmaceutical industry. Assisted in development and validation activities of CIP systems and as well as COP systems such as bottle washers and ultrasonicators as well as manual cleaning processes. Responsibilities and experience included:Worked in cGMP environments and trained in aseptic sampling techniquesAssisted in Operational Qualification and Sequence Of Operations testing Assisted in execution of cleaning validation and clean hold time studies, equipment grouping strategy and sampling plan developmentAssisted in Cycle Development activities including hydraulic balancing, parameter development, recovery study execution including swab and rinse, and cleanability studies Protocol drafting, execution and reportingDeviation investigationAssisted in Engineering review of CIP systems including system trouble shooting, VST development, P&ID review, air blow and design review for validatability

Consultant in the Cleaning Validation department

Assisted with research on permeable reactive barriers for use in removing heavy metals from mine drainage waters. Research was conducted on passive remediation techniques and included microbial analysis. Responsibilities included:Microbial species identification of communities existing in column studies DNA extraction from soil samplesDNA amplification using Polymerase Chain Reactions (PCR)DNA purification using Denaturing Gradient Gel Electrophoresis (DGGE) and DNA cloning using E. coli cells IR spectroscopy used for DNA extraction yield and contaminationExperimental designPerformed work in an anaerobic environment Column effluent evaluation using pH monitoring, turbidity testing for sulfate levels and metal digestion for ICP prep Gas chromatography performed on gas samples taken from batch studies