Process Automation/MES Engineer

Martha W. Lee

** ******* ******,

Jersey City, NJ 07306

Cell: 513-***-****

ad5q26@r.postjobfree.com

Strength & Qualification:

A Senior Process Automation/MES Engineer with experience in supporting global, pharmaceutical, oil and gas, Energy, Petrochemical, and manufacturing industries.

Experienced in Advanced Cell Therapy process Design, configuration, integration and implementation of process control solutions for various industries. Develop P&IDs and loop descriptions for various plants, processes, and/or equipment.

Experienced in performing Computer System Validation (CSV) in Process Automation System (PAS) including Distributed Control System (DCS), PLC, SDLC Software Developing Life Cycle in developing, implementing and maintaining regulatory control, advanced process control strategies using HP ALM.

Experienced in project management and commissioning of control systems, DCS/PLC, SIS, Bio Reactor Batch Processing, including application software programming and Human Machine Interface (HMI) using Emerson Delta V Batch, Honeywell EXPERION PKS, Wonderware (Archestra, Intouch, System Platform, Skelta Workflow,

Historian), GE UniCorn, PlantPAx, RSLogix 5000, and Allen-Bradley HMI/PanelView, Building Automation System. Knowledgeable of Electrical, Mechanical, Control/SCADA, PLCs, AC / DC drive systems, industrial control system protocols, (Controlnet, Devicenet, Profibus, Profinet, BacNet and Ethernet/IP), DCS (Delta-V), Process Improvement Methodologies, and Root Cause Analysis (RCA).

Familiar with Upstream and Downstream unit operations (centrifugation, filtration, precipitation, chromatography, bioreactors, CIP/SIP, mass flow technology, etc.).

Develop User Requirement Specifications (URS); Develop software and hardware design specification; Design, program, implement, test and document various DCSs. Develop control system validation/testing protocols.

Familiar with ISA 88, 95 standards in supporting Level 2,3, 4 systems and applications. Experienced in providing technical leadership in support of site deployments of Emerson Syncade (MES) including Emerson DeltaV (DCS), Infobatch (reporting), and SAP Execution systems and network infrastructure.

Education:

M.S. Chemical Engineering, Oklahoma State University, Stillwater, Oklahoma

Graduate Study in Physical Chemistry, Oklahoma State University

B.S. Chemical Engineering, National Cheng-Kung University, Taiwan

Graduate Study, Computer Engineering. Science, Loyola College, Maryland

Skills:

Experience in PAS and MES technologies: Syncade, Delta V, PlantPAx, OSI PI and Database technologies.

Proficient knowledge of a lab system includes Empower, LIMS, FCS Express, Flow Cytometry and other QC bench top systems/equipment etc.,

Understanding of engineering documentation such as P&IDs, Process Flow Diagrams and SOPs of ISA S88, S95 and Batch Processing

Experience in cGMP’s and multi-national biopharmaceutical/cell therapy regulations and batch process control in the life science industry with validation Knowledge of 21 CFR Part 11 requirements.

BeiGene, Hopwell, NJ 01/16/2024- Present

Sr. Automation/MES engineer

Responsible for the Batch Recipe Authoring FAT and SAT for the BeiGene Hopwell Manufacturing site including Batch Recipe commissioning, EMS and Batch Production using FactoryTalk PlantPAx system. Define and author the following various Recipe objects including: Data Evaluate: Evaluate an output value. Obtain PlantPAx/PLC Batch Functions: Create and remove a batch campaign. Equipment Check: Scan equipment barcodes to validate equipment status and properties. Equipment Events: Perform events on multiple pieces of equipment within a single equipment class. Material Functions: Perform material inventory functions. Display Message in User Interface. Print Label: Print labels based on type and parameters. Perform functions on a specified scale: including connection, change unit of measure, tare, read, zero, reset, read tare, scale information, and reset tare. Dispense in Workflow: Dispense items for a given weigh sequence using the Weigh and Dispense module. Area Dispense and Charge. Recipe Objects were created for the standardize common workflow recipe operations offering to access fully supported work instructions, behaviors, and web services.

Thermo Fisher Scientific, West Hills, CA 11/08/2023- 01/12/2024

Tecan Automatic Liquid Handling Qualification and Validation

Responsible for Tecan Fluent 1080 IQ. OQ and PQ and dotting volume characterization studies.

Sanofi Biologics, Framingham, MA 12/14/2022- 7/28/2023

Sr. MSAT Process Automation & MES Engineer

● Provide technical expertise in Gene and Enzyme cell production troubleshooting and root cause analysis for process discrepancies and quality investigations of a complex technical nature in process automation and controls including Delta V, BMS, MES and OSI PI Data Historian. Lead, participate and document risk assessments and HazOps, lead root cause investigations and develop corrective actions, act as PSM MOC Coordinator, complete monthly air permit compliance reports, quarterly research reports, assigned monthly safety inspections/audits, summarize and present data to management, liaise with other departments and sites to provide professional support and advice.

● Responsible for developing, implementing and maintaining multi-variable, model based, predictive control applications for the cell therapy bioreactors including cell density monitor, PH, temperature and Do controls,

● Assist in reviewing the electronic batch record (EBR) MES Recipes and related Enterprise Resource Planning (ERP) system master data in Werum PAS-X MES, including, but not limited to, items, specifications, lookups, list of values, recipes, routings, and formulas.

Define and author the following various Recipe objects including : Data Evaluate. Obtain Delta V Batch Functions, Equipment Check, Equipment Events, Material Inventory Functions, Display Message in User Interface. Print Label, Perform functions on a specified scale, Dispense in Workflow, and Area Dispense and Charge. Recipe Objects were created for the standardize common workflow recipe operations offering to access fully supported work instructions, behaviors, and web services.

● Develop and maintain standard operating procedures (SOPs) and documentation related to Delta V systems, ensuring compliance with regulatory standards such as FDA regulations (e.g., 21 CFR Part 11).

● Perform system testing, validation, and qualification activities, including developing and executing test protocols and documenting results.

Pfizer, Sanford, NC 05/02/2022- 06/03/2022

Pfizer, Kalamazoo, MI 01/10/2022- 03/18/2022

Sr. Process & Automation Engineer

Responsible for delivering simple to complex changes to application or recipe build within the MES solution scope includes software(recipe) components, configuration, recipe and object libraries, interfaces, reports and any customizations that support the Digital Plant manufacturing operations

Used PharmaSuite to develop MES solutions including recipe, configuration and/or system changes to meet business requirements.

Responsible for the MES recipe authoring and software development. Troubleshooting plant floor MES execution and business system integration issues. Compliance with corporate and site business processes, valid design principles, and quality procedures

Responsible for Process Automation System (PAS) and Manufacturing system Qualification and commissioning. Executing test scripts, work with IT and implementation team to execute installation qualification and define configuration specification including reviewing Functional Design Specification (FS), Detail Design Specification (DDS) and Computer System Validation CSV using Rockwell PlantPAx PLC/SCADA Batch Programming. Reviewing recipe software design, modification and Equipment/Control Module implementation & Batch Programming.

BMS (Celgene), Warren, NJ 02/15/2021-01/07/2022

Sr. Process Automation & ECQ Engineer

Responsible for the MES recipe authoring and software development. Troubleshooting plant floor MES execution and business system integration issues. Compliance with corporate and site business processes, valid design principles, and quality procedures Also responsible for the Cell Therapy Development Operation (CTDO) Juno Xuri Technology Transfer including Delta V Process Automation System (PAS), Laboratory Information Systems (LIMS), Equipment Commissioning and Qualification including. Responsible for the Design, Author, and Execute Computerized System Validation (CSV) including viewing User Functional Requirement (URS), Functional Design Specification (FS), Detail Design Specification (DDS), Trace Matrix, Validation Summary Report), SOPs, IQ,OQ,PQ, according to GAMP 5 guidance. Review Delta V Batch Recipe software design, modification and Equipment/Control Module implementation & Batch Programming. Execute Delta V Batch test scripts.

Define and author the following various Syncade Recipe objects including Data Evaluate. Obtain Delta V Batch Functions, Equipment Check, Equipment Events, Material Inventory Functions, Display Message in User Interface. Print Label, Perform functions on a specified scale, Dispense in Workflow, and Area Dispense and Charge. Recipe Objects were created for the standardize common workflow recipe operations offering to access fully supported work instructions, behaviors, and web services.

Responsible for Delta V batch Record Integration using PI Asset Framework, PI Vision, PI ACE, PI Webserver, PI Analytics, PI Notifications, PI Tags.

Vopak, Houston, TX 11/4/2020– 1/05/2021

Sr. Delta V Process Automation Engineer

Responsible for Vopak Yosemite GCGV Corpus Christi Delta V & PLC/SCADA Process Automation System (PAS) Project including reviewing User Tank Route Selection System, Vapor Combustion Unit’s User Functional Requirement (URS), Functional Design Specification (FS), Detail Design Specification (DDS) and Computer System Validation (CSV using Delta V DCS Batch including IQ,OQ,PQ and reviewing recipe and route selection and tank farm automation movement software design, modification and Equipment/Control Module implementation & Batch Programming.

Used Syncade to build Master Recipe for Tank Material Inventory and Management.

Merck, Sharpe &Co Inc., Rahway, NJ 07/2020– 10/9/2020

Sr. Delta V Process Automation Engineer

Reviewed computerized systems validation documents such as: Requirements Specification, Design Specification, CSV Risk Assessment, Test Plans, Test Summary Reports, Data Migration Plan, Pre/Post Executed Test Scripts, Traceability Matrix, to Production Statements.. Ensure continuous laboratory data integrity and identify any data integrity issues.

Used Syncade to build Master Recipe for Material Inventory and Management and Equipment Tracking.

Responsible for setting up CTU Temperature Mapping, cell culture equipment/process, single use bioreactors, single use mixers, wave bioreactors, CIP/SIP systems, AKTA / Chromatography. Also responsible for the CSV using Delta V DCS & PLC/SCADA Batch including the recipe creation, modification and Equipment/Control Module implementation & Batch Programming.

ExxonMobil GCGV MEG Project, Houston, TX 10/2019 – 04/30/2020

Sr. Process Application Engineer

Responsible for the quality review and approval of validation and change control documentation such as protocols, test plans, various validation testing documents, deviations, and change controls for GCGV MEG SDLC and CSV using Honeywell EXPERION PKS TotalPlant Batch andPLC/SCADA.

Merck, Sharpe &Co Inc., Elkton, VA 09/2019 – 10/1/2019

Sr. Delta V Process Validation/Automation Engineer

Responsible for the daily process automation and troubleshooting for the Vaccine Backend Production for the Delta V Process Automation System (PAS) Batch process and PLC/SCADA including the recipe creation, modification and Equipment/Control Module implementation & Batch Programming; performed quality review and approval of equipment validation and change control documentation for B5H Primaxi Bulk Filling etc

Used Syncade to build Master Recipe for Material Inventory and Management and Equipment Tracking.

SGCE Energia, Pasadena, TX 08/2018 – 07/2019

Sr. Process Automation/Control/Validation Engineer

Responsible for FT GTL Juniper Delta V & PLC/SCADA Process Automation System (PAS) Basic, Batch and Advanced Complex Process Control such as Control Narrative, protocols, test plans, various validation testing documents, deviations, and change controls for GCGV MEG SDLC and CSV. Reviewed computerized systems validation documents such as: Requirements Specification, Functional Specification (FS), Detail Design Specification (DDS), Installation Qualification (IQ), Operation Qualification (OQ), and Performance Qualification (PQ) and Complex Control Narrative Definition, Factory Acceptance Test and Site Acceptance Test.

Stora Enso Biomaterials, Raceland, LA 11/2017 – 02/2018

[Global diversified Paper & Pulp, Biomaterial Company]

Process Automation Engineer

Support process control on daily review of existing basic process control applications includes:

Responsible for in daily processes control and operation & troubleshooting from the field devices (valves, transmitters, sensing elements, analyzers, pump and compressor stations, flow meter, etc.) through the controller (which includes Process Automation System (PAS), DCS, PLC. Performing routine work efforts to maintain and improve process control utilization and reliability using Rockwell FT PlantPAx Batch and Allen Bradley.

Automation & Validation Solutions, Blue Bell, PA 05/2017 – 11/2017

[System Integration Company in Pharmaceutical & Biotech industries]

Sr. Process Automation Commissioning Engineer

Responsible for Process Automation System (PAS) & PLC/SCADA implementation in life science and pharmaceutical manufacturing and Life Science Lab builds. Review MEP design, HVAC, P & ID engineering drawings. Also deal with POs, Contract, etc. Also used Syncade to build Master Recipe for Material Inventory and Management and Equipment Tracking and project management and commissioning and Qualification of control systems for GlaxoSmithKline and Taiwan Op Nano Pharm.

Intech Process Automation Inc., Houston, TX 04/2014 – 09/2015

[System Integration Company]

Sr. Process Automation Engineer

Develop and document designs for Process Automation System (PAS)/PLC/SCADA instrumentation, electrical & Amp; control systems for field personnel on Chevron CDB Natural Gas Project .

Responsible filed instrument spare parts specifications for KivuWatt Gas Extraction Facility Project and testing for William Energy ULC –Canada Feed Gas Dryer Package Control System including function analyses and sequence control checking. Using and Allen Bradley PLC control logic. Responsible for Process Gas Solution Grand Chenier Regeneration gas furnace Optimization project using Allen Bradley PLC., RS Logix 5000 programming, Operator interface design.

Maverick Technologies, LLC, Houston, TX 06/2013 – 01/2014

[System Integration Co. for Oil& Gas, Food, Pharma. & Petrochemical industries.]

Sr. Process Automation Engineer

Responsible for Dow Chemical, Texas Operation, and Freeport Copolymer polypropylene (CPP) Process Automation System (PAS) Debottlenecking Batch Process Control project implementation. Involved in all three phases of projects; 1) front end loading (early project planning, FEL / FEED), 2) detailed design and construction, and 3) commissioning and startup. Develop control software and operator graphics.

Develop S-88 compliant batch specifications and configuration of Process Control System database configuration and simulation software / checkout graphics and complete the factory acceptance test (FAT). Involved in Safety Integrity Level (SIL) determination, Safety Instrumented Systems (SIS), and designed the basic process control system (BPCS) operators.

Self Employed, Houston, TX 04/2007 – 05/2013

Process Automation Consulting Engineer

Project management for processing plant wide BPC/SIS system project proposal and management using Rockwell FT PlantPAx Batch, Emerson Delta V, PROVOX, RS3, Aspen DMCSPlus and Honeywell Experion DCS systems. Provide process automation, computer system validation (CSV) and process engineering integration consulting works.

Utilizing Syncade to build Master Recipe for Material Management for Taiwan Cyanide and Taiwan Glaxo Smith Kline to meet FDA guideline and GMP regulations.

L3 Communication, Cincinnati Electronics, Mason OH, 08/2002 – 04/2007

[Diversified vendor for DOE projects in Special Bio-Chemicals and Optical Products]

Sr. Process Automation Engineer, Biomaterial Products

Responsible for utilizing Syncade to build Master Recipe for Material Inventory and Management and Equipment Tracking. Responsible for daily process control and batch processing using Delta V. Utilizing Statistical Process Control (SPC), Root Cause Analysis & Corrective Action tools and to conduct RCCA for related issues

Intel Massachusetts, Inc. F17 – Hudson, Massachusetts 05/2000 – 08/2001

[Leading Global Microprocessor Manufacturer]

Sr. Process Engineer

Performed Support Pentium IV P860 (0.25 um) technology transfer including i-line Nikon stepper Photolithography process and Cu plating in Class 1 Clean Room in F17. Daily Process sustaining and Improvement including SPC Chart & process capability monitoring, defect reduction and utilized statistical data analysis software JMP, Crystal ball to perform the yield analyses.

Anadigics Inc. Warren, New Jersey 07/1997 – 09/1999

[Microwave IC Manufacturer]

Senior Process Engineer

Utilize Statistical Process Control (SPC) to provide daily production and process support for Group III-V GaAs MESFET RF Microwave and optical electronic devices manufacturing process, wastewater treatment and ASML i-line Photolithography, operation workstation coordination in Class 100 Clean Room.Performed daily miss processed wafer analyses using 8D & 5 WHY, analyzed defect Root Cause Analyses (RCA) cause .

Fu-Tai Engineering Consulting Co. Taipei 01/1990 – 04/1995

[Leading Taiwan EPC Company]

DCS Process Automation System (PAS) Manager, DCS System Section

Project management for Oil refinery, petrochemical and pulp & paper processing plant wide process control system project proposal and management using Honeywell TDC 3000, FOXBORO I/A and Emerson PROVOX, RS3, and Delta V DCS systems. Participated in factory acceptance testing (FAT), site acceptance testing (SAT) commissioning and start up in Chinese Petroleum Corp. (CPC) oil refinery plant wide integrated DCS systems.

Fisher Taiwan Agent-Lumux International Inc. Taiwan 09/1988 – 05/1990

[Leading Fisher Control Instruments & PROVOX DCS Vendor]

Account DCS Sales System Engineer

Support direct sales, system implementation using Emerson PROVOX, RS3 for process control projects. Interfaced with customer plant management, and upper management. Developed, executed sales plans for key accounts and identified new business opportunities to meet or exceed annual sales order and revenue plans.

UPC Resources (Now: Valero Refining Co.) – Wilmington, CA 08/1987 – 08/1988

[Oil Refinery]

Advanced Process Control Engineer

Process sustaining for the Coker, Crude Fractionator and FCC CAT daily unit monitoring & analysis and evaluate catalyst and chemical performances & cost. Support Honeywell TDC 3000 Process Control System operation and SETPOINT Advanced Process Control and optimization.

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