Summary

Work experience

• Senior Automation Engineer

  Stellix Global Services

  2026.04-Current

  (4 months)
• Automation Engineer

  Process Engineering Specialists

  2023.08-2025.12

  (2 years)

  - Contract with Lonza • Supported commissioning & Operation Qualifications (simulations, manually syncing equipment, updating batch parameters, etc.). • Investigated pre-CQV issues and developed programming solutions for test batches to support new manufacturing area startup. • Reviewed programming and change controls for both new plant automation and tech transfers. • Reduced customer facing parameters and created simplified recipes to support tech transfers. • Designed new/modified programming for plant to plant WFI transfer to limit the impact of maintenance activities. • Perform investigations and design/implement resolutions for tech transfer issues. • Supported development and execution of plant projects with other functional groups (i.e. MSAT, MES, and Engineering). • Owned/supported review/approval of Change Control Requests, Corrective/Preventative Actions, and Commissioning Test protocols (Kneat, TrackWise, and Workfront). • Created/updated Functional Specifications, Design Specifications, and Configuration Specifications
• Senior Process Development Associate

  AGC Biologics

  2021.08-2022.03

  (8 months)

  • Completed laboratory start-up for viral vector based processes ranging from bench scale to full scale production. • Performed process evaluation and facility fit for upstream operations, supporting tech transfer and client business case development including materials lists, identification of new or modified equipment, and process mapping. • Led sub team for implementation of new equipment and technology for the PD laboratories. • Created and updated PD batch records, process calculation spreadsheets, and associated documentation for client tech transfer demonstration batches. • Owned process transfer of pilot scale upstream Lenti viral vector development activities while collaborating with MSAT and manufacturing to ensure full scale cGMP production readiness. • Designed and executed development studies to determine appropriate ranges of process parameters. • Filled in gaps with client information package by researching client products and utilizing industry expertise. • Wrote protocols, planned experiments, analyzed and interpreted results. • Presented experiment data and discussed results at client project team meetings.
• Manufacturing Specialist

  Novartis Gene Therapies

  2020.02-2021.07

  (a year)

  • Performed process evaluation and facility fit for upstream operations, supporting new product introduction, and technology transfer to the manufacturing site including BOM creation, identification of new or modified equipment, and process mapping. • Functioned as document and operations owner providing scientific/technical support to manufacturing staff while ensuring Data Integrity, and cGMP compliance. • Led/supported troubleshooting and mitigation efforts for the resolution of deviation investigations, and process issues to determine the impact, root cause, and corrective actions. • Collaborated with Engineering, MSAT, QA/QC, and the Supply Chain functions providing required process input to support manufacturing operations. • Served as operations Subject Matter Expert for single-use process path design and implementation. • Owned manufacturing process/equipment related change controls and provided scientific/technical support on various project deliverables. • Performed loop tuning on PLC controlled bioreactors for global engineering alignment project. • Investigated bioreactor control issues, and supported DeltaV controlled plant water project. • Actively identifies and implements potential equipment or process improvements set to improve manufacturing capabilities. • Trained staff on operations, new systems/equipment, CAPAs, and change controls ensuring process/equipment updates are clear and maintain the quality of materials or products, processes, personnel safety.
• Manufacturing Specialist (w/ Process Development duties)

  ImmunityBio, Inc.

  2018.07-2020.02

  (2 years)

  • Completed a GMP clinical manufacturing plant start-up for a viral vector based immunotherapy within 8 months. • Re-engineered the platform process from limited bench scale and CMO data. • Performed process evaluation and facility fit including materials, and identified the required equipment for the platform process to be implemented in the GMP manufacturing facility. • Participated in start-up efforts of new equipment and processes to bring manufacturing online. • Wrote automated equipment recipes and performed loop tuning (unicorn based systems). • Ensured clean and sterile operations by designing a single-use process path. • Actively identifies and implements manufacturing procedure improvements intended to optimize the platform process and ensure regulatory and safety requirements for clinical patients. • Provided scientific and technical support for process related issues and investigations. • Planned and performed process development batches to investigate process issues. • Created and updated SOPs, MBRs, process calculation spreadsheets, and associated documentation for manufacturing processes. • Participated in FMEA risk evaluations to help determine risk level, mitigations, and acceptance criteria.
• Manufacturing Specialist

  Rezolute, Inc.

  2017.07-2018.04

  (10 months)

  • Produced API and sterile microsphere formulations under cGMP practices through processes such as chromatography, tangential flow filtration, pegylation, lyophilization, and emulsion. • Performed aseptic fill/finish drug product activities in an ISO 5 environment to meet clinical study needs. • Day-to-day troubleshooting and maintenance activities, identification of process improvement and optimization opportunities. • Owned engineering project sub-tasks and initiatives supporting operational-critical objectives. • Worked on equipment/systems improvement projects reducing the need for manual intervention. • Worked on equipment/systems improvement projects reducing the need for manual intervention. • Updated PLC based emulsion system recipes and process parameters. • Authored production documentation, SOP's and change controls, as necessary. • Trained and coached technicians and new staff on operations and safe equipment handling.
• Automation Programmer III (Controls Engineer)

  Logical Systems LLC

  2015.04-2017.07

  (2 years)

  • Developed programs for Distributed Control Systems (DCS) and Programmable Logic Controllers (PLC). • Developed and modified Human/Machine Interface (HMI) packages to work with the PLC/DCS. • Designed and executed testing plans for DCS and PLC programs to effectively test all aspects of a new program or program changes. Simulation of control loops and I/O. • Lead programmer for multi-system brew kettle replacement utilizing PCSD library and DeltaV batch. • Integrated an ABB based filtration system into a DeltaV controlled brewery production line with Mynah virtual I/O interface cards. • Coached junior engineers on DeltaV programming and troubleshooting. • Led DeltaV introduction class for Coors technicians. • Oversaw electrical controls construction at the client’s site and verified that the system was installed as designed. Provided technical support to the construction effort. • Performed I/O checkout on the installed control system and documented the checkout results. • Provided post-commissioning support to the client’s operations, engineering, and maintenance personnel. • Helped troubleshoot non project based issues and coached client technician’s hereby reinforcing client relations. • Created, updated and maintained requirement / design documents, Piping and Instrumentation Diagrams (P&IDs) for various systems. • Updated and created OSI PI tags and historical trends/process books. • Evaluated client trends and historian data to assist with reducing COGM and batch issue investigations.
• Process Development Pilot Plant Associate - Equipment SME (subject matter expert)

  Amgen

  2012.06-2014.12

  (3 years)

  • Functioned as equipment owner and subject matter expert for 14 skids and associated support systems in the process development group, with duties including commissioning new equipment (IQ, OQ, PQ), modification and repair of existing equipment and process qualification. • Created, updated and maintained requirement / design documents, job plans, change control records, Piping and Instrumentation Diagrams (P&IDs) and preventative maintenance records for various systems, ensuring compliance with company policy and cGMP standards. • Developed solutions to technical problems of moderate scope and complexity within area of expertise, assuring equipment alignment with other sites while meeting the needs of one off experiments. • Collaborated and built constructive relationships within group/team and across network to support engineering projects and equipment maintenance. • Increased DO probe reliability by >30% while serving as main point of contact for Pilot Plant instrumentation (e.g. flow meters, DO and pH).
• Process Development Pilot Plant Associate - Process Lead

  Amgen

  2011.04-2014.12

  (4 years)

  • Served as upstream (cell culture/fermentation) and/or downstream (protein purification) lead for floor operations to support process characterization and commercialization of human therapeutics. • Monitored and addressed critical process parameters, in the cell culture/fermentation process, cell wash, cell lysis, centrifugation, protein chromatography, viral inactivation, and UF/DF (Tangential Flow Filtration), ensuring systems met acceptance criteria. • Performed analytical analysis of product samples ranging from absorbance, cell counts, and percent solids to nutrient profiles. • Trained and coached new and temporary staff to operate independently, increasing ability to meet major milestones by spreading work load. • Collaborated with process engineers to design experiments and draft experimental procedures. • Drafted SOP’s, MP’sand other technical documents, exceeding department adherence to timeline average by 60%. • Utilized Human Performance and Lean Manufacturing tools to ensure safety and quality of all operations while improving Key Process Indicators (KPIs).
• Process Development Pilot Plant Associate - Automation Lead

  Amgen

  2005.07-2014.12

  (9 years)

  • Avoided down time by serving as main point of contact in several labs for all automation activities in the process development group. • Designed, programmed and tested custom automation solutions for equipment/process improvements and facility fit of incoming process transfers,ensuring alignment with other sites utilizing Emerson DeltaV DCS. • Implemented selectable gassing strategies for 32 small scale reactors increasing the system flexibility to meet individual experiment requirements. • Created and maintained alarm notifications using OSI PI tools,preventing a potential loss of $75,000 and two months of work per batch. • Designed and implemented PI Process books and batch trends for the process development team to monitor batch performance real time and collect report data from the continuous historian. • Established relationships with automation staff from internal departments to help support 20+ automated systems. • Enhanced operational efficiency by updating the HMI through User Experience Design.
• MIC Technician

  BD Pasco

  2004.01-2005.01

  (a year)

  • Assisted with set up of batch fills (operates autoclaves, assembles equipment, and Creates labels). • Cleaned manufacturing equipment per established procedures to prevent product contamination. • Ensured product quality by performing environmental monitoring during batch fills. • Validated repairs of damaged equipment by performing equipment qualifications (installation, operation, and process). • Guaranteed compliance during operation of aseptic GMP batch fills while operating manufacturing equipment. • Maintained current training with FDA regulatory and GMP requirements, cleanroom gowning techniques, and in-house Standard Operating Procedures. • Perform standard operating procedures involving basic laboratory techniques, calculations, materials measurement, operation of laboratory equipment and record keeping necessary to manufacture BD products.
• Manufacturing Technician/Engineer

  FERX INCORPORATED

  2002.01-2004.01

  (2 years)

  • Performed validation, calibration, maintenance and repair on all laboratory and manufacturing equipment according to written procedures in a BioPharma GMP environment. • Initiated and tracked work orders to ensure timely completion. • Assured lab systems were ready for use by performing annual equipment reviews and equipment qualifications (installation, operation, and process). • Gathered experiment data through careful operation of manufacturing equipment during aseptic GMP batch fills. • Developed manufacturing equipment experiments designed to increase efficiency of batch production. • Maintained current training with FDA regulatory and GMP requirements, cleanroom gowning ISO Class 6, and in-house Standard Operating Procedures. • Created and maintained SOP’s and other technical documents to meet compliance requirements. • Hired as permanent after three months as a temp for Kelly Scientific Resources.

Educational experience

• Westwood College

  Bachelor’s of Animation, Graphic Design
• Front Range Community College

  Associate of Science, General Science