Lawrence — Lead Control & Automation Systems Engineering Consultant Lead

January 2014 - Present Lead Control & Automation Systems Engineering Consultant Lead, manage and implement projects with significant improvement potential in the manufacturing processes worldwide for biotech and pharmaceutical clients; develop and implement strategies that improves our clients process systems success in market place; set direction for new and cutting edge controls and automation methodologies; work with customers to integrate patent tested and proven engineering solutions into their processes; generate technical proposals, engineering process guidance and conduct specification reviews; direct automation engineers in creation and maintenance of methods, practices, tools and standard practice and, work with clients and suppliers to develop and deliver controls and automation solutions that meets the current cutting edge in the clients industry. PALL CORPORATION

Automation & IT Systems Manager June 2012 - June 2013 Lead and manage Automation Engineering Team; develop and implement automation strategies that improves PALL's process systems success in market place; set direction for the automation development activities in North America; work with customers to integrate PALL automation solutions into their process including technical proposals, process guidance and specification review; direct automation engineers in creation and maintenance of methods, practices, tools and standard practice and, work with suppliers to develop and deliver controls and automation solutions that enhance PALL leadership in Life Sciences market place. SHIRE PHARMACEUTICALS, INC

Wave Bioreactor Nodes Integration to Network April 2011 - February 2012 Provided, managed and coordinated the automation design and support for the integration of the Ten (10) Wave Bioreactors to the manufacturing system network. Designed and modified the existing control system to integrate the Wave Bioreactors to the network using the Mod-Bus network protocol. The bioreactors were standalone individual systems that were not visible to the operations personnel. The integration allowed the status and alarms to be visible and also collection of historical data. In addition, revised all automation engineering specifications and documents impacted, developed the CTPs and supported the Validation and QA activities related to the project. The project was delivered on-time with minimal budget variance

Operator Interface Terminals (OIT) Remediation Project August 2010 - September 2011 Managed, coordinated, designed and implemented the modifications to the OIT software to resolve all operational issues that were discovered during CSI Phase 1 and Phase 2 in all the eighteen (18) SCADA Nodes Siemens PLCs in Biotech manufacturing floor with revised GE iFIX SCADA node software; In addition, developed and executed the Commissioning Test Plans (CTP) and supported the Validation and QA activities associated with the project. This was done without downtime to manufacturing operations. The project was completed on time and within budget

August 2009- July 2010 Control Systems Improvement (CSI Phase 2) Project: PLCs Managed, coordinated, designed and implemented the upgrade of all eighteen (18) Siemens PLCs from 315 to 317 CPUs in Biotech manufacturing floor with new hardware and revised software; In addition, developed and executed the Commissioning Test Plans (CTP) and supported the Validation and QA activities associated with the project. This was done without downtime to manufacturing operations. The project was completed on time and within budget

August 2008 - July 2009 Control Systems Improvement (CSI Phase 1) Project: IT Systems Managed, coordinated, designed and implemented the upgrade of all eighteen (18) SCADA Nodes in Biotech manufacturing floor with new hardware and software; replaced the Historian and Web Portal Servers with a Primary and Back-up Historian in a fail-safe design; replaced the isolated Domain Controller with a corporate Domain Controller for users authentication; added a wireless connection between the manufacturing suites and the office suites to ensure fail safe data transmission; isolated the manufacturing network into three (3) manageable virtual LANs and; connected the manufacturing LAN with the Corporate LAN via Firewall to eliminate multiple log-in credentials and allow continuous back-up of valuable GMP data. In addition, developed associated SOPs/EPs and supported the Validation and QA functions related to the project. This was done without downtime to manufacturing operations. The project was completed on time and within budget

April 2007 - June 2012 Lead Process Controls & Automation Systems Engineer Project engineering management, controls engineering support, manages and coordinates internal and external engineering activities to implement and launch engineering projects. Provides support for large scale commercial manufacturing processes, prepares justification for engineering projects, participates in troubleshooting and resolution of process equipment issues to avoid manufacturing downtime, identifies continuous improvement opportunities and implements process improvements and provides support in GMP investigations. Provides on-going process support for downstream and upstream processes including cell culture and protein purification manufacturing operations and provides input on existing manufacturing gaps, sources of variability leading to opportunities for process improvement. Additional responsibilities include support for Facilities Equipment such as Clean-In-Place (CIP), Water for Injection (WFI), Kill Systems and Building Maintenance Systems. Directly designs and/or reviews and approves process controls systems specification, design, commissioning, SAT, FAT and final installation and training. Conducts machine safety risk assessment and implements the electrical controls design consistent with the current national and international industry standards. Participates in FDA investigations and provides all required documentation to support the change control process. Provided Controls Engineering advice to Process Engineering, Facilities Engineering, Manufacturing Department and Corporate Leadership as part of the on-going continuous improvement strategy. DELPHI SYSTEMS, INC

CIP Skids Instrumentation & Pump Safety Enhancements April 2007 - September 2007 Managed, coordinated, designed and implemented the replacement of all analog based process instrumentation with digital, Profibus PA process instruments. Conducted the commissioning, reviewed the validation protocol and assisted with the validation of the CIP system. The upgrade eliminated downtime caused by obsolete analog instrumentation, enhanced the diagnostics capability and elevated the safety level of the acidic, caustic and main supply pump to a level consistent with ANSI B11/EN954-1 Category 2. The project was completed on time and within budget. Completed Projects at Delphi Systems

Senior Electrical Controls Project Engineer October 2001 - April 2007 Responsible for world-wide technical specification of design and approvals of new industrial machinery for GM Steering Columns and Intermediate Shaft Business Line relative to national (NFPA & NEC) and international codes and standards (IEC) as required by the Delphi Machine Acquisition Process. Participated in the Manufacturing System Design, Machine Design Reviews, Gate Reviews and Final Qualification and Acceptance. Responsible for conducting the operational risk assessment, reviewing and approving the machine controls designs, PLC and HMI design and programming, conducting the pre-runoff functional and construction check, and overseeing the successful transfer and launch at the receiving Delphi plant SIMS PORTEX, INC/SMITH MEDICAL INC

Senior Electrical Controls Engineer May 2001 - October 2001 Provided automation project and floor support for manufacturing and an electrical control system to a high-speed automated assembly machines for various combinations of hypodermic needle syringes. Analyzed the manufacturing processes to identify areas of improvement. Prepared the capital project packages to fund projects, selected multidiscipline teams, and executed projects as planned. Provided engineering assistance in FDA Validation, and Specification and Approval of Equipment. Periodically reported project status to a division leadership team. Trained technical and production personnel on new equipment. POLAROID CORPORATION

October 2001 - April 2007 Automotive Steering Systems Assembly Design Projects Managed, coordinated, designed and implemented and launched over seventy five (75) control systems of automated and semi-automated manufacturing equipment systems for the assembly of hydraulic and electrical power steering columns. Through-out the course of the projects, functioned in a project leadership role, Subject Matter Expert of electrical designs and safety circuits, reviewed and approved designs and machine builds, conducted qualification runs, oversaw the installation and ensured a successful launch including operator training. Some of the equipment included, Presses, Slip-load testers, CNC Lathes, Single and Double end Extruders, Plastic Injection Machines, Final Steering Assembly Lines, Mills, Rotary Swaggers. The technology covered all of the listed areas of expertise above. The customer base included Ford (US), Toyota (Mexico), Fiat (Poland), Opel (Poland), General Motors (US) and Suzuki (India). The project budgets ranged from $2.0 to $20 million dollars. Completed Projects at Polaroid

Manufacturing Production Supervisor August 1997- April 2001 Held responsibility for managing the Polar-pulse battery pre-assembly production team and delivering the annual financial and operational goals. Supervised 18 multi-skilled operators, two off-shift supervisors, and two technical trades' personnel. Participated in the development of a training plan for the new WAM II assembly machine and provided managerial support for the scale-up program

Chemical Mix System Upgrade Project January 1996-July 1997 Designed the PLC-based automated control system design to replace an obsolete PDP 11/73 DEC system with an Allen Bradley PLC-5, increasing runtime from 88% to 98%. Coordinated and communicated project activities within the division. Responsibilities included representing the manufacturing concerns of the division within the design team. Managed the project budget of $2.2 million

January 1996-July 1997 Vacuum Sealer Temperature Control System Upgrade Prepared a $300,000 capital work order package to upgrade the existing temperature control system of the vacuum sealing process. Selected and managed the design team in designing the new PLC-based automated control system. Improved the control system by replacing the unreliable EMC controls with an Allen Bradley PLC-5, and an Intellution (GE Proficy) machine interface system

Battery Tester System Upgrade Project April 1995-February 1996 Prepared a $70,000 capital work-order package to replace the obsolete P-770 battery tester systems with computer-based test systems. Designed the electrical, successfully delivering the units on time and within budget. The failure rate of 24% was virtually eliminated

Cathode Pocketing System Upgrade Project January 1995-February 1996 Prepared a $1 million capital work-order package to redesign the Cathode Pocketing subsection of the battery assembly machine. Conducted Paretto analysis to assess system strengths and weaknesses. Emphasized the uses of current design techniques and technology to achieve the design objectives without exceeding cost and time constraints. Selected and managed the multidiscipline design team. Designed the electrical control system. The result was a reduction in downtime from 12% to less than 3%

Scrap Removal System Project July 1993-January 1994 Prepared a $50,000 capital work-order package to replace the obsolete relay controls system of the Rotary Battery Assembly Machine with a modern Allen Bradley SLC 500. Designed the control system, selected all components, stocked spare parts, updated schematic drawings, and supervised implementation. The system provided operation convenience for controlling the factory-wide scrap system

Automated Robotic Packaging System Project July 1992-January 1994 Designed the electrical and control systems and provided support for the installation and operation of the system. Developed the robot control logic and interfaced PLC system to the PUMA 562 Robot Control System. This project eliminated five on-line packers' positions for total annual savings of $100,000 to $120,000

Process Control System Upgrade Project January 1990-July 1992 Prepared a $200,000 capital work-order package to upgrade a section of the existing distributed control system. Evaluated the control system components from various vendors. Selected the compatible system and implemented the upgrade on time and within budget. The machine down time caused by this section was reduced from 7% to fewer than 2%. Computerized Data Acquisition System (Northeastern University Co-Op Project) August 1988-April 1989 Designed, developed, implemented, and documented a software package to automate the data acquisition and analysis for the Bubble and Peel Force Tester machines. Wrote the "C" language program and implemented the tester successfully

Electrical & Process Controls Engineer June 1989-July 1997 Provided on-going floor electrical controls support for manufacturing and electrical controls systems to a highspeed automated Rotary Battery Assembly machine (RBAM) and the Chemical Batch Mixing operations. The RBAM support required expertise in Distributed Control Systems, a Synchronized Multi-Axes (18) Servo Control System, Closed Loop Web Unwind Stands, Miscellaneous Instrumentation Modules, Pick & Place Systems, Robotic Programming, Vacuum Sealing Process and On-line High Speed Cognex Vision System. Prepared capital project packages to fund projects, including funding for the design team. After project implementation, applied improvement metrics to assess impact of project

Provided, managed and coordinated the automation design and support for the two (2) Bioreactor Perfusion modifications. Designed and modified the existing control system to accommodate an additional Media Tank, an additional Harvest Tank; replaced and automated the Harvest System DTT pump; and, replaced the manual 28 Day Bioreactor cycle process with a heavily automated process that guided and alarmed the technicians throughout the cycle. In addition, revised all automation engineering specifications and documents impacted, developed the CTPs and supported the Validation and QA activities related to the project. The project was delivered on-time with minimal budget variance