Process development & scale-up
- Fermentation and cell culture process development
- Parameter screening, DoE, and design-space definition
- CPP/CQA identification, control strategy, and SPC
- Scale-up from ambr 250 through 4 kL
Work
Process &ManufacturingEngineer
Process engineer with over a decade of GMP experience spanning operations, engineering, project management, maintenance, bioprocess scale-up, facility and equipment commissioning, and manufacturing data systems.
Fremont, CaliforniaPharmaceutical Process Engineer
10+ yearsof GMP engineering and manufacturing experience
Flask → 4 kLbioreactor scale-up
>90%reduction in manual data workflows
50%OPEX cost reduction
Focus areas
What I work on.
Pilot plants & capital projects
- Facility startup and process-utility assessments
- Equipment specification, selection, and procurement
- FAT, SAT, commissioning, IOQ, PPQ, and validation
- PFDs, P&IDs, design reviews, and automation integration
Manufacturing & operations
- Production scheduling, capacity planning, and CDMO oversight
- Equipment reliability, maintenance, and calibration
- Lean, Six Sigma, 5S, Kaizen, Kanban, and visual management
- Root-cause analysis, CAPA, and continuous improvement
Data systems & automation
- SQL- and Excel-based process data systems
- Dashboards, historians, and statistical visualization
- Ignition SCADA, DeltaV, FactoryTalk, PI, and PLCs
- Python, Power BI, SQL, JMP, and web app development
Experience
Role history.
Mar 2024–Present
Staff Engineer, Pilot Plant
Vaxcyte · San Carlos, CA
- Launched a new fermentation pilot facility, leading equipment specification, procurement, installation, and commissioning.
- Developed pilot USP batch records, ELN templates, work instructions, and automation recipes, and trained staff on equipment operation and routine maintenance.
- Built a custom online data historian that unified seven standalone units and avoided more than $100K in licensing fees.
- Developed SQL- and Excel-based data systems and dashboards that reduced manual workflows by more than 90%.
- Served as USP MSAT representative and technical authority for a CDMO clinical manufacturing facility.
- Scaled fermentation and CFPS processes from ambr 250 systems to 30 L and 4 kL, and identified more than $75K per batch in potential improvements through SPC analysis.
Jun 2022–Mar 2024
Senior Process Engineer
GOOD Meat (Eat Just) · Alameda, CA
- Led FAT and SAT execution for stainless-steel and single-use cell culture equipment supporting pilot and manufacturing operations.
- Led scale-up and optimization studies involving kLa, P/V, tip speed, and parameter screening.
- Managed a plant-wide Ignition SCADA and historian implementation integrating Siemens and Allen-Bradley PLC systems.
- Defined scale-up parameters from flask culture to a 3.5 kL bioreactor and achieved at-scale KPI targets.
- Built an Excel visualization tool that reduced routine graph-generation time by 95%.
- Achieved a 100% batch success rate in 2023 and implemented modifications that cut operating costs by more than 50%.
Jun 2019–May 2022
Manufacturing Process Engineer
Codexis · Redwood City, CA
- Doubled capacity for an E. coli-based 15 L protein production line by repairing critical equipment and qualifying additional bioreactors.
- Managed a $3M program replacing obsolete bioreactors, centrifuges, and lyophilizers.
- Served as SME for fermentation, filtration, centrifugation, homogenization, and lyophilization.
- Transferred fermentation processes into 15 L pilot bioreactors and scaled them to 650 L stainless-steel systems.
- Implemented a 21 CFR Part 11-compliant CMMS and achieved 100% on-time calibration and maintenance.
Aug 2016–Jun 2019
Manufacturing Engineer
AstraZeneca · Redwood City, CA
- Commissioned and qualified a new API production line and reduced campaign deviations by 93%.
- Implemented and validated a process that increased weekly output by 60% using existing equipment and headcount.
- Improved batch success from 88% to 97% through equipment reliability, simplified documentation, and training.
- Led continuous process validation and reduced facility product changeover from three weeks to one.
- Reduced manual batch-record entry by 50% through automated reporting and documentation improvements.
Jul 2013–Jul 2016
Process Engineer
Bayer · Berkeley, CA
- Delivered analytical process-equipment CAPEX projects valued up to $1M within 5% of budget.
- Led a sitewide reliability initiative that replaced more than 100 obsolete instruments.
- Established process ranges for commercial products through statistical analysis and evaluated new bioprocess measurement technologies.
- Designed preventive maintenance and calibration plans and trained more than 300 operators and maintenance technicians.
Processes & utilities
- Fermentation
- Cell culture
- Centrifugation
- Homogenization
- Purification
- Filtration
- TFF
- Lyophilization
- Spray drying
- WFI
- Process gases
- Steam
- Chilled water
Software & automation
- Excel
- Python
- Power BI
- SQL
- JMP
- SAP
- TrackWise
- Veeva
- Smartsheet
- DeltaV
- Ignition SCADA
- FactoryTalk
- PI
- PLCs
- MES
- Claude Code
- Codex
Documentation & compliance
- SOPs
- Batch records
- Deviations
- Investigations
- CAPA
- Change control
- URS
- FMEA
- Traceability matrices
- 21 CFR Part 11
- 21 CFR Parts 210 & 211
- ICH Q7–Q12
- FDA inspections
Education & credentials
B.S., Bioengineering & Materials EngineeringUniversity of California, Berkeley · May 2013
Lean Six Sigma Green BeltInstitute of Industrial and Systems Engineers (IISE) · 2015
Google Data Analytics CertificateDecember 2023