Sofie Gonzalez Email & Phone Number

Philadelphia, Pennsylvania, United States

Dunboyne, County Meath, Ireland

• Managed engineering deliverables with shift engineers to drive on-time completion of technical transfer and validation deliverables.
• Site Manufacturing Controls Quality Risk Assessment owner, facilitating SME discussion to document key process-related risks.
• Authored validation protocols for the start-up facility, training and qualifying technicians in cleaning validation sampling.

Durham, North Carolina, United States

• Supported the Process Support and Media team as document owner for SOP workstream and CAPA investigation owner.
• Created and implemented of the material management workstream in start-up to transfer and store 4,500+ single use materials.
• Led operational readiness between operations, warehouse, quality release, and procurement to ensure delivery of material on the floorfor 3 Engineering and 6 PPQ batches.
• Assisted in Divisional and European Medicines Agency audit events through the request management team.

Millsboro, Delaware, United States

• Facilitated site and regional/US Animal Health Hoshin Kanri (HK) events. Streamlined HK process by building dashboards to visualizestrategic alignment and highlight resourcing needs of Large Molecule initiatives.
• Performed freeze dryer and freezer capacity visualization analyses for new product transfers to US sites.
• Verified master data and optimized manufacturing flow in model area to increase resource utilization through labor analysis and 5S.
• Lead Facilitator for 3 Day Kaizen Blitz to enable >85% utilization of available time for the freeze dryers on site.

West Point, Pennsylvania

Collaborate with a team of engineers and scientists to diagnose molecular weight discrepancies within serotypes associated with PNEUMOVAX®23. Authored, executed, and analyzed results from a protocol that investigated mixing phenomena in novel manufacturing system. Participated in lab scale experiments for comparison and ideated on observations from both.

Modesto, California Area

Executed chemical characterization and quantitation of wine carbohydrates in novel varietals following personally- optimized extraction and purification procedures. Reported data to peers and Research Chemistry Department senior scientists. Received preliminary training on HPLC and Ion Chromatography.

Modesto, California

Worked with the innovation team to design a bottle outfitted with novel sensor technology (dubbed “Robo-bottle”) for assisting mechanics with line set-ups and commercial-speed line diagnostics. Worked on business case development. Aided in creating experimental plans and injection molded samples for a new screw-cap liner (named “Gfresh”) technology that.

Documenting bottling lines and creating a calendar of standard work to ease the assimilation of new hires to the production engineering department.

Specializing in legal transcription and filing.

I am an Advanced Peer tutor for children in a class called Success Skills. The class is designed to help underachieving students reach their true potential by inspiring them to work hard and giving them the tools and support they need to achieve. In the class, children learn about time management, peer communication, higher education, and job development..

Bse: Chemical And Biological Engineering

Education record

Activities and Societies: Mock Trial, Piano, Tennis, Enochs High School Leadership