Responsible for ensuring equipment uptime in multiple Reagent Manufacturing labs at Roche Sequencing Solutions. This involved implementing, optimizing, and troubleshooting processes, as well as maintaining lab equipment in a fast-paced GMP environment. I also provided ongoing support for transferred processes and contributed to manufacturing excellence.Responsibilities:Served as Santa Clara site SME for SAP Plant Maintenance (PM) module implementation, providing critical expertise.Drove equipment uptime in Reagent Manufacturing labs through implementation, maintenance, troubleshooting, and optimization of automated and manual processes.Delivered engineering technical support to Reagent Manufacturing operations, proactively resolving issues.Troubleshoot complex problems by collaborating with cross-functional teams, conducting root cause analyses, and developing optimal solutions.Created and maintained data, technical files, and other quality documents related to operational equipment, ensuring compliance and data integrity.Partnered with MSAT team to ensure seamless manufacturing excellence across global sites.

Support the safe, reliable, and compliant operation of the facilities/utilities used by Manufacturing Operations. This includes investigations and troubleshooting of equipment failures, supporting maintenance and calibration activities, and implementation of small capital projects (<$100k).RESPONSIBILITIES:First responder for any facility/utility equipment or system breakdown.Investigate facility deviations, troubleshoot equipment failures, conduct root cause analysis, develop corrective and preventative actions (CAPA), and implement appropriate fixes.Assist in facility upgrades, compliance, renovations, repairs, and annual shutdown activities.Oversee maintenance and project activities, ensuring that they are performed on time, within budget, and to quality and safety standards.Support the SAP, Plant Maintenance (PM) module implementation at the Redwood City site as an SAP Super User.Provide engineering input for two sites by acting as the Facilities, Engineering, and Maintenance (FEM) PMO Representative, serving on Safety Committee, and Problem-Solving Investigation Task Force.

Working with several group members on a weekly basis produced 7,000+ vials from more than 100+ products requiring excellent teamwork and aseptic technique. This involved organization of required materials, documentation, dispensing product mixtures, lyophilization, capping, and labeling under Good Manufacturing Practice (GMP) conditions. Also, coordinated with Customer Service, Technical Service, and Quality Control Departments monthly to produce special order vials of high value and custom product orders typically shipped the same day.Significant Contributions: Provided technical assistance to management and co-workers about freezing/thawing for protein solutions, diluting, lyophilization, spectrophotometry, endotoxin analysis, pipette calibration, volumetric and gravimetric measurements, product reconciliation, safety reviews and general troubleshooting of manufacturing operations.Led special project to investigate product lyophilization deviations that resulted in more than 3 product lines having a significant improvement in quality.Proposed Six Sigma and Lean Manufacturing concepts that simplified several production processes, reduced department paper waste by 50%, and increased the throughput of the department's production system.Evaluated information from vendors and made recommendations to purchase new equipment that resulted in a more efficient and ergonomic dispensing process for the department.Reviewed standard operating procedures (SOP’s), protocols, technical instructions, and specifications for accuracy and errors developing new ones as necessary.Trained 3 group members to prepare from the raw materials sterile carrier, excipient, and buffer solutions by filtration and pH adjustment that mix with final products that resulted in 100% of lots made for 7+ years showing no contamination.

Prepared yeast cell culture media and solutions using aseptic technique.Sterilized lab equipment and solutions using an autoclave.Maintained laboratory supplies.

Prepared samples for experiments under good laboratory practices (GLP) conditions.Participated in testing experiment samples.Maintained laboratory supplies.