Our consultants are positioned to meet a variety of our client’s needs in the Pharmaceutical, Biotechnology, Medical Device, Food, Beverage and Chemical Industries. These consultants have multi-level plant in Operational Technology (OT). From sensors and controllers on the manufacturing floor, through HMI SCADA, PLC’s, DCS, Data Historians, Manufacturing Execution Systems (MES) at the information level, IT coordination and design to connect to enterprise systems as well. In addition, our staff includes very experienced Project Management resources with a long track record of success.
Areas of expertise includes:
- Industry 4.0 design for current and future connectivity
- Pharmaceutical product drug life cycle
- Manufacturing processes and coordination with process engineering internally on the client side, including engineering firm support for the process design
- Product, process and system life cycle
- FDA and regulatory compliance, cGMP’s and GAMP for GxP systems
- Serialization / Traceability
- Process Analytical Technology (PAT) and definition of design space
- Continuous Processing in Pharma Manufacturing
- Quality by Design (QbD)
- Process Analytics and Operational Intelligence
Owner’s Rep – design, manage, execute and project manage capital engineering projects on the client’s behalf, providing industry, OEM automation and Information and Operational Technology (IT/OT) expertise.
Technical Consultant – develop a scope of work (SOW) on the clients behalf, addressing the project requirements: examples include:
- Site surveys of automation systems
- Developing an Automation Technology Road Map
- Developing the path forward for the implementation of:
- Data historians, system, site and enterprise level systems
- Manufacturing Execution Systems (MES)
- Batch systems at the system level and connected to MES
- Smart sensor technology
- HMI SCADA systems
Technical Services – develop an assessment document / Feasibility Study on the client’s behalf, bringing all the elements of knowledge together including:
- ROI to address Operational Excellence (OpEx)
- Continuous improvement
- Scale-up and other transformational technologies.
Training – develop a training course targeting key senior executives on automation and information buzz words / technology trends. This training will inform and enable executives, project owners and steering committees to better understand and justify which capital projects to “green light” to meet their operational and business needs.