James S. Pike

Tustin CA, *****

Cell 949-***-****

ad28nx@r.postjobfree.com

www.linkedin.com/in/james-pike-53893b183/

Automation Engineer

System Development Process Development Project Management

Experienced Controls Engineer with over twenty years of experience in designing, optimizing, implementing, remedying, and validating custom industrial production systems. I have taken projects from initial design through Installation, Operation, and Performance qualifications.

Engineering Expertise

Project Management

Process Development

Custom Control System Development / Upgrades / System Integration

Equipment/Software prototyping, debugging, startup, remediation, and commissioning.

cGMP CAPA (Corrective and Preventative Actions) experience

Calibration Methodology & SOP development

cGMP Compliance and Validation

Software skills include PLCs: Allen-Bradley PLCs (RS Logix, MicroLogix, ControlLogix, factory talk, PLC 5, & SLC 504); OMRON PLC, Automation Direct (Direct06 Programmable Logic Controller & C-MORE HMI Panels); Wonderware InTouch HMI (Human Machine Interface) software; iFIX 4.0, Delta V, Microsoft SQL Server & Wonderware Industrial SQL Server; Crystal Reports; AutoCAD; Visio, Maximo & Blue Mountain CMMS software.

Experience:

PSC Biotech (Mar 2021 – Sept 2023)

Irvine, CA

Contract Validation Engineer

Metrology Support and Critical Parts Support (Bachem)

Performed calibration on various temperature and pressure devices and generated calibration reports.

Lyophilizer Recommissioning Project (Teva)

Generated master instrumentation and components lists for determining required preventative maintenance and calibrations.

Redlined PID drawings and Electrical Schematics to reflect the current system.

Media-Cartridge Project (FujiFilm)

Wrote and executed Branson Hot plate welder IOQ to make weldments.

Programmed Instron to test weldments made on the Branson Hot Plate Welder.

Wrote and executed IOQ on the Instron to test weldments generated on the Hot Plate Welder IOQ.

Wrote and performed a Powder Formulation PQ for the powder used on the Media Cartridge project.

Edwards Lifesciences (Sept 2014 – Sept 2020)

Irvine, CA

Controls Engineer, Maintenance Group

Facilitated the maintenance and upgrade of industrial production equipment while observing Good Manufacturing Practices (cGMP) and established validation standards. Analyzed control systems and created/modified electrical and piping & instrumentation drawings (P&IDs) to reflect the current status. Performed Validation and troubleshooting for control software, system hardware, RO water systems, autoclaves, chemical sterilization systems, and more. Programmed across various control applications, including PLC 5, Control Logix, Factory Talk, Mitsubishi, and Festo.

Performed multiple CAPAs (Corrective and Preventative Actions) to remediate quality issues causing production downtime or impacting regulatory compliance of production and support equipment.

1.CAPA for improper autoclave CGMP door operation: Repaired software and performed SWV over the weekend to remedy operational compliance issues and returned to production.

2.CAPA for vacuum leak test failure: Reviewed vendor utility connections and found an installation discrepancy. I updated utility connections and executed the IQ addendum showing updated utilities, PID drawing, and maintenance procedures before returning to production.

CAPA-related process improvement: Performed process testing to help determine the cause of bag breakage during autoclave sterilization for a new autoclave being validated. Demonstrated that process optimization and improved product loading reduce/eliminate bag breakage issues.

Reliability CAPA improvement: Repaired and revalidated PLC 5 software and wiring controlling plant chemical distribution, reducing unscheduled downtime. Software repairs stopped chemical distribution pumps from tripping during storage tank switchovers and enabled better batch data display recovery after system crashes from power losses. Repairs were distributed across 2 CAPAs that were implemented/validated over weekends.

Supervised the installation of two autoclaves with integral clean steam generator installations (Belimed & Getinge)

Edwards Lifesciences (May 2014 –Sept 2014)

Irvine, CA

Contract Software Validation Engineer

Completed validation preparation work necessary to make equipment ready for Validation. Executed software validations after completion of repairs, process development, and specifications.

Schmid Press wire-form crimper: Rebuilt, reconfigured, and re-validated a wire crimper used to make frames for replacement heart valves that had been offline for nine months. Wrote and executed software validation (SWV) and performance qualification (PQ) qualifications for this equipment.

Branson ultrasonic welder: Took over the project to prepare the equipment for production. Developed user specifications operations manual, modified Festo PLC & HMI software, followed by performing process development. Wrote and executed software validation (SWV)

Schneider Electric Professional Services Power Logix Group (July 2013 – February 2014)

Tustin, CA

Contract Electrical Engineer for Port of LA and Long Beach

Facilitated high-voltage electrical switchgear commission to utilize city power for powering ships during docking, ultimately reducing 35,000 volts to 6,000. Redlined electric drawings as needed, configured power instrumentation, and troubleshot wiring issues / PLC software. Executed commission testing.

Compass Water Solutions (November 2009 – July 2013)

Irvine, CA

Instrumentation & Controls Engineer

Designed and programmed small control systems to support maritime water treatment, including RO systems and oil water bilge separation systems.

General Responsibilities

Generated New Schematics & designed control panels for various control systems to support Technical Sales specifications and electrical requirements such as NEC, IEC, and ATEX.

Generated and updated P&ID drawings for customer requirements

Wrote the Factory Acceptance test procedure (FAT) and tested the control system upgrade before installation.

Generated Control Logic and Instrumentation Loop Diagrams

Performed hardware, software, and instrumentation setup and troubleshooting.

Generated user manual for the operators

Programmed PLC & HMI programs from the ground up (RS Logix/Factory Talk & micrologix/panelview component) (systems varied from stand-alone to SCADA)

Mangan, Inc. (May 2007 – May 2009)

Long Beach, CA

Principle Engineer

Responsibilities varied by the project for the Tesoro and BP refineries in Long Beach.

BP Alky Compressor Rebuild project

Generated New Schematics for the control cabinet replacement (this is a relay control system with a hard-wired Annunciator Panel)

Redlined P&ID and generated Logic Diagram drawings for changes done to the system

Generated test procedures, user manuals, and FAT. Tested the control system upgrade before installation.

Flow Orifice Verification and SPI Implementation Project

Defined and verified critical process parameters for liquid flow (primarily petroleum or water), gasses (primarily hydrocarbon or steam), and steam for flow orifice calculations using SPI software.

Support work for other projects

Generated Safety Instrumented Systems Logic Diagrams and validation procedures.

Barry-Wehmiller Design Group, Inc. (December 2006 – May 2007)

Cerritos, CA

Project Engineer

Responsible for developing, executing, and summarizing all lifecycle documentation for equipment, computer systems, and processes for pharmaceutical, biotechnology, and medical device clients.

Delta V configuration and FAT testing (SCADA system)

iFix conversion from iFix 3.0 to iFix 4.0 (SCADA system)

iFix and Crystal Reports Alarm Report Configuration and FAT testing document

Generated Electrical Drawings for a control cabinet upgrade.

Fluid Research Corporation (July 2006 – October 2006)

Tustin, CA

Consulting Engineer

Worked as a consulting PLC Controls engineer for Fluid Research Corporation, designing custom PLC software and HMI interfaces. Responsibilities included generating Functional Requirement Specifications, Electrical Drawings, Test Fixtures, HMI Software, hardware integration, documenting communications configuration, and training staff engineers on the new control systems as part of project turnover.

Software Development: (OMRON, Automation Direct, C-MOORE HMI Panels)

Programmed single vacuum and two vacuum degassing skids with the Dual A and B Vacuum degassing and tank exchange FRS. Used specifications to make custom communications cables so devices would communicate.

Set up test fixtures to pre-test and debug the control software before integrating it with the vacuum degassing skids to shorten startup time.

Washington Group International (June 2002 – July 2006)

Validation Engineer/Consultant

Responsibilities entailed writing and performing system validations (Installation, Operational, and Performance Qualifications), participation in factory acceptance testing for the client, including review of mechanical and electrical drawings, executing functional testing of equipment (PLC loop checks, alarms, security, and process execution), and generating recommendations to remedy functional requirement or cGMP compliance discrepancies.

Sanofi Pasture Pharmaceuticals (Working for Washington Group International)

I Supervised eight validation specialists for FAT, Commissioning, and IQ/OQ Qualifications for a flu vaccine preparation building. This building contained three Formulation skids, one buffer prep skid, portable transfer tanks, filling skids, and tank CIP & SIP skids. Responsibilities included the following activities:

Generated Device Documentation Spreadsheet Template for skids with up to 600 components to be used with validation protocols.

Generated cGMP Weld Documentation Spreadsheet Template for skids with up to 1600 process welds to be used with validation protocols.

Wrote IQ and OQ Protocol Templates and supervised the execution of IQ and OQ protocols.

Wyeth Pharmaceuticals (Working for Washington Group International)

Factory Acceptance Testing Performed

Autoclaves (Primus Sterilizer in Omaha, NE)

Nutsche Press Filter (Comber in Bergamo Italy)

cGMP Glass Washer (Steris in Quebec City, Quebec)

Systems Validations

Low Humidity Rooms, Freezer Rooms, and other HVAC systems

Laboratory RODI System

Hot and Cold WFI System

Compressed Air System

B.Braun Medical Inc. (September 1995 – May 2002)

Irvine, CA

Sterilization Equipment and Process Development Engineer

Worked as a Project Engineer developing and supporting sterilization processes, equipment, and control software.

Production Autoclave Simulator Project:

Performed a hardware and software programming upgrade on a simulation autoclave with a Wonderware HMI (operator) Interface, Allen Bradley PLC process control, and secure SQL server data control.

Hardware Development:

Demonstrated that changing internal spray nozzles would decrease heating and cooling temperature ranges by 2/3. This change proved that major plumbing upgrades were unnecessary, saving the company $50,000. Upgraded analog input cards and wiring to reduce floating ground issues and make calibration easier and more accurate.

Design and Functional Specifications:

Developed functional specifications for the sterilization processes this autoclave could run.

Developed batch and recipe reports.

Developed control system overall definition for the HMI (human-machine interface), PLC (programmable logic controller), SQL server database structure, and systems communications.

Wrote upgraded Operation, Maintenance, and Calibration Procedures.

Process/Software Development

Designed and implemented a process control system upgrade for functionality, performance, and Validation.

PLC Ladder Logic Control (RSLogix5 for Allen-Bradley series 5)

Optimized ladder logic reduced coding by 80%, greatly decreasing system response time and delays.

HMI (Human Machine Interface) Logic & Screen Flow (Wonderware)

Designed and developed an operator panel flow schema around a primary process control window that shows process equipment status (P&ID format), process status, alarms, and operation control pushbuttons. Total number of Wonderware windows was reduced by 75%.

SQL Server & Crystal Reports

Upgraded SQL database tables and Stored Procedures for implementing a new batch report setup and a simplified Recipe storage database.

Autoclave with integrated class 100 unloading isolator project (supporting an aseptic fill line):

Functional Specifications:

Reviewed, modified, and approved OEM Electrical, P&ID, and Mechanical drawings and finalized functional specifications with the vendor.

Developed an electronic machine communications protocol between the autoclave, the mating half-suit isolator, and a VHP (vaporous hydrogen peroxide) generator. This automation saves six man-hours per decontamination cycle and eliminates human error from manual decontamination.

Process/Software Development

Developed steam sterilization processes for metal parts, tubing, & plastic jar sterilization.

Developed VHP sterilization software integration for the autoclave and half-suit isolator and performed VHP sterilization PQ (Performance Qualification)

Combined similar cycle phases to eliminate duplicate code and simplify Validation and debugging. The final control code had 25% fewer phases and 35% less code than the OEM software.

Validation:

Took the entire project from equipment specification through IQ (Installation Qualification) and OQ (Operational Qualification) testing. Autoclave OQ testing included full-capacity dummy product loads with thermocouples and biological.

Johnson & Johnson Sterilization Technology Group (January 1994 – July 1995)

New Brunswick, NJ

Contract Engineer

Worked as a contract engineer for the Johnson & Johnson Sterilization Technology Group. The job entailed designing custom mechanical systems and programming the control software on two prototype Chlorine Dioxide Sterilization Chambers. I helped evaluate an Ethylene Oxide sterilizer in Shanghai, China.

Functional Specifications:

Wrote the systems definition documents (SDD) for the Chlorine Dioxide Sterilizers. These documents defined the sterilizer subsystems, processes, and HMI (Human Machine Interface).

Software Development: (Honeywell PC Supervisor, Intellution, & Macintosh Hypercard)

Designed and programmed the HMI interface, ladder logic, and continuous control logic.

Programmed a fluid mechanics program to calculate gas pressure drops through piping, valves, and orifice plates for gases and liquids with different specific gravities and viscosities.

Equipment Design, Implementation, and Installation:

Designed piping, test fixtures, and continuous upgrades while performing process development on the first prototype Chlorine Dioxide sterilizer.

Supervised the transportation, installation, and commissioning of the second sterilizer.

Dow Jones Inc., (1990 – 1992)

South Brunswick, NJ

Electronic Technician

Worked full-time as an electronic technician performing mechanical and electronic component level repair on microprocessor-driven personal computers and printers.

Professional Credentials

University of California Irvine

Certificate of Advanced Software Technology, October 2000

The College of New Jersey

BS Engineering Science, May 1993: Concentration in Mechanical Engineering

Carnegie Mellon University

BS Metallurgical Engineering & Material Science, May 1988

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