Our Experience.

Tim Malyszko is a recognized expert in the industry, with over twenty years experience in controls and automation engineering and strategic planning around manufacturing modernization efforts. He has extensive experience leading projects, leading operations and leading staff in manufacturing and engineering services organizations. 

PARTIAL LIST OF PROJECTS

Ongoing Digital Transformation Projects

  • Providing consulting services and guidance related to Industry 4.0 investments for a $2.4 billion private equity firm.
  • Developing a preliminary plan for a small discrete manufacturer with several pending patents to incorporate IIoT functionality, data analysis, and predictive maintenance into the manufacturing process and the end product.
  • Developing a control system and plant floor networking modernization plan for a life sciences manufacturer with limited cutover opportunities due to demand exceeding current capacity.  

Life Sciences – Contract Manufacturing Facilities Expansion

  • Worked with customer to develop the controls scheme for a new API derived from natural enzymes. The new system consisted of approximately seven hundred I/O points, seventeen process units and fifty sequence of operations.
  • Managed the Process Control Team.
  • Wrote I/O Verification Documents, Logic and HMI Verification Documents and Alarm and Interlock Testing Documents for System Validation. 
  • Led execution of Installation, Operational and Performance Validation for the new system.  

Life Sciences – Controls System Upgrade and Validation Plan Development

  • Upgraded existing Lyophilization and related processing equipment of pharmaceutical intermediaries to bring the systems in compliance with Title 21 CFR Part 11.
  • Coordinated the development and execution of the Validation Master Plan. 
  • Developed Installation and Operational Qualification Protocols to validate the new automated processes. 
  • Developed validation documentation to retroactively validate automation equipment to bring the documentation in compliance with regulations.  

Specialty Chemicals – Brownfield Plant Expansion

  • Led process control system team for a $55 million expansion that spanned twenty-four months. 
  • The project spanned over forty processing and storage units including the automation of two reactor trains, a new tank farm and a new truck/railcar receiving and unloading operation. 
  • The expansion included a significant amount of shared unit and shared headers requiring extensive handshaking between units along with lot tracking and product tracking. The purpose was to prevent cross contamination of both raw materials and finished products through both the expansion and tie-in points to the existing facility. 
  • The expansion included a fully simulated mass balance and energy balance used for both automation testing and training new operators for the facility.  

Specialty Chemicals – Synthetic Lubricants Automation

  • Specified all the controls required to automate a manual operation. This scope included specifying the control system along with all field devices required for the project. 
  • Managed the process automation development along with the mechanical contractors and electrical contractors. 
  • Deployed a virtualized PlantPAx Process Automation System that included traditional I/O, Foundation Fieldbus I/O. 
  • Migrated paper written batch reports to complete paperless reports available through a web portal, thus serving up reliable data to plant management.  

Nutritional Products – Liquid Process Plant Expansion

  • Designed and developed the Control System User Requirements Specification / Functional Requirement Specification for a $9 million plant expansion. 
  • Managed the automation team and oversaw the design, development, implementation and testing phases for the project. 
  • Developed mass balance process simulation and basic energy balance process simulation to test control logic before on-site implementation. 
  • Reviewed process design to identify opportunities for simplifying control and improve efficiency.  

Nutritional Products – New S-88 Based Process Control System

  • Designed, Programmed and Tested S-88 Based Logic. 
  • Provided both on-site support and remote support during start-up and production along with the validation period.
  • Developed Training Material targeted towards Operator and Maintenance personal unfamiliar with the S-88 architecture. 
  • Developed Process Simulation using VPLINK.  

Pharmaceuticals – DeltaV Electronic Signature Implementation

  • Retrofitted existing Operator Action Request Global Logic to capture electronic signatures. 
  • Since the Operator Action Request Logic was used throughout both batch logic and equipment module logic, the code had to be modified so that it worked flawlessly with the existing validated logic. 
  • The electronic signature username and password verification used the existing DeltaV/Windows Security; therefore, an additional username database was not required. 

Pharmaceuticals – Heat Exchanger Process Design

  • Sized a new heat exchanger to reduce viscosity of final products to ease product filling. 
  • Completed a full mass and energy balance around associated pumps, piping and filters to verify the proper sizing and specified the proper equipment where required.  

Automotive Finishes – Production Facility Control System Upgrade

  • Translated existing PROVOX code into a design specification for the new ControlLogix S-88 based control system. 
  • Developed a low to medium fidelity mass and energy balance simulation using VPLINK to assist in the testing of the ControlLogix and GE Fanuc Proficy Batch Control System.  

Oil and Gas – Helium Facility Upgrade and Gas Well Integration

  • Replaced Moore APAC’s System and obsolete PLC, which integrated ROC data from gas wells using RF transmissions.
  • New control system operated main and remote facility. 
  • Data/controls located in main facility as well as corporate headquarters.  

Chemicals – DeltaV Design and Implementation

  • Developed DeltaV control system to replace old PLC (with panel board interface and single loop controllers).
  • Incorporated “best practice” into fully automated control system that managed flow from continuous process to batch process then back to continuous process. 
  • New system greatly improved efficiency, versatility and productivity.  

Chemicals – Reactor Project Upgrade

  • Developed detail design and instrumentation specification to automate facilities reactors. 
  • Utilized PC Chart and Batch Record automation.  

Chemicals – Functional / Detail Design Specification Development

  • Developed functional specification using existing SOP’s and P&ID’s along with the customer’s input 
  • Utilized a class base approach and conformed to S-88 standards.  

Pharmaceuticals – Control System Migration

  • Reduced a FIX32 Dynamo Set from over 100 dynamos to less than 30 iFIX dynamos. 
  • Wrote and executed the Validation Master Plan for the dynamo development, graphics conversion and control systems migration. 
  • Converted over 250 validated displays to iFIX using the new iFIX dynamo set.  

Pharmaceuticals – Bulk Waste System Upgrade

  • Added controls to existing system to accommodate new tank. 
  • Implemented code to determine type and destination of bulk waste. 
  • Wrote/executed validation protocol.  

Pharmaceuticals – Control System Design Consultation

  • Provided guidance to third-party integrators on customer’s existing control standards. 
  • Developed new standards specific to the facility. 
  • Provided start-up coverage.  

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