Life Sciences & Pharmaceutical

Successful engineering has to align everyday production with the big picture. Each processing unit and work cell must come together with your automation system to form not only an efficient production process but also one that matches your business goals and realities. When we present an automation solution to you, we make sure it matches your budget, your timeline, your current production realities and your goals, all while minimizing risk.

Our Front End Engineering Design (FEED) sets the foundation for a successful project accomplished on time, on budget and in a way that fits your in-house team.

If the needs of your business, plant and production line change over time, our systems come ready to change along with them. And if you need, we’ll even tweak the system design to fit the skill sets of your support team. We believe the best systems change for you. It shouldn’t be the other way around.

Once the FEED is completed, you will receive:

• Outlined Business Objectives
• Project Timeline & Budget

In our detailed engineering and design service, we transform the conceptual into the final design. We use all the knowledge we gain from the automation solutions site assessment and Front End Engineering Design (FEED) to minimize your risk, get you running quickly, and align our work with your business realities. Here we will also flush out project risks, planning for them by nailing down a realistic project budget, execution plan and timeline.

Malisko both designs your automation system and implements it. Our detailed engineering and design service picks up right after our FEED services leave off, and our system integration execution picks up right after our detailed engineering and design. We can handle the complete package: specification, design, procurement, development, on-site execution, troubleshooting and support of the control, network, security and MES layers.

During this phase, we can provide you with:

• Drawing Packages
• Documentation
• Hardware & Software Specification
• Industrial IT Infrastructure Design

After we’ve completed our thorough automation solutions site assessment, Front End Engineering Design and Detailed Engineering Design, we have the information we need to document, code and integrate your automated system. We keep in mind your business goals. We factor in the strengths and limitations of your team, and we prioritize your most important objectives.

We design your system on a foundation of understanding so that we can rapidly implement it with absolute precision. We program each function in your system and set up an intuitive Human Machine Interface (HMI) and reporting that allows your team to adopt your system efficiently. We outfit your system with the reporting you need to stay on top of your production. Prior to installation, we run your system through several rounds of intensive testing in a simulated environment to make sure it works. Once we have programmed your machines, set up your HMI, created a useful reporting program and tested the functionality and performance of your system, it is time to install your system in your facility. When on-site system installation is complete, our team again extensively tests the operation, performance and functionality of the new system holistically from the field devices through to reporting.

During this phase, we can provide you with:

• Programming & Logic Development
• Human Machine Interface (HMI) Development
• Reporting
• System Integration Testing & Simulation
• On-Site Process Commissioning

Computer System Validation (CSV) is a must in FDA-regulated industries. We design and implement your system to deliver consistent, efficient production that also meets CSV for FDA. And we prove it too. If you operate in a regulated industry, we take care of the paperwork related to CSV and reduce your Regulatory risk. We can provide a Validation Master Plan (VMP) and use it to guide our work. We document requirement specs, design specs, functional specs, test plans, installation and operational protocols, trace matrices and summary reports. We execute the protocols as well. We assist with keeping your records up-to-date via change control and help keep your system in compliance. Minimizing risk is ingrained in our company because we are committed to delivering you ROI.

During this phase, we can provide you with:

• Computer System Validation Documentation
• Executed Validation Protocols
• Electronic Records

If any troubles emerge with your system, we have you covered, whether it is warranty or support under a formal service contract. When you work with Malisko Engineering, you don’t just get a system, you get a whole team to support it. If you have a full maintenance and system support staff on hand, we will provide assistance to fill the cracks. As much as practical, we can help your team be properly equipped to maintain and troubleshoot your process and automation system. If you need full support services, we are available 24/7 to make sure your system works.

During this phase, we can provide you with:

• Post-Commissioning Technical Support
• Remote Support