Innovation for Health.
Our company’s mission is to provide the highest quality of Manufacturing consulting services within FDA regulated industries: pharmaceutical, biotechnology, food and beverage.
Consulting Services for the following: Manfacturing, Engineering, Automation, Validation, and Project Management. See Services section for additional information.
Our company has a focus on avoiding the downtime that can come with aspects of any new role, consultants and full-time employees alike, for aspects of any new job within FDA regulated industries, such as getting familiar with the Automated systems for the process of a specific company, down to getting assigned the right Curriculums needed to gain access to systems without significant downtime. Being aware that consulting can be a temporary role within companies where our services are provided, we aim to give our customers the most time efficient, as well as highest quality services. Such examples include focusing on getting familiar with our customer’s Learning Management System, IT Service Center, and any other associated Requesting Tools required for gaining access needed. This could be for ensuring access to Servers through Remote Desktop Protocols are being requested, to examples as simple as receiving an Adobe Acrobat Pro license to Edit PDFs. Understanding every FDA regulated company has a high standard of quality to uphold, which always comes with a large list of SOPs and Trainings to ensure all employees are aware of the standards and compliance required, it’s important to also focus on the aspects of gaining the access needed to perform our services in parallel, knowing the onboarding process may take weeks to months.
Doug’s started his career with a Bachelor’s degree from the University of Massachusetts Lowell in Chemical Engineering, with a focus in Biological Engineering and Minor in Biomedical Engineering. Since then, his career has taken many roles throughout the Pharmaceutical/Biotechnology industry, starting in Upstream Manufacturing a Bristol-Myers Squibb, then working as a Technical Support Engineer on Watson-Marlow Peristaltic Pumps, followed by an over 3-year span with Regeneron Pharmaceuticals working in various Automation roles, including: start-up of a Factory Talk Site Edition (SE) system for a new Fill/Finish facility and building of an AVEEVA PI system for a whole site. He then pursued a role through Repligen as an Automation Engineer for their Single-Use Tangential Flow Filtration (TFF) systems, with a focus on programming of Allen-Bradley PLCs through RSLogix and HMIs through iFix SCADA software, though many hats were able to be worn in this role that involved setting up of Single-Use Flow-Paths, Programming/Calibrating of all Instruments: Pumps, Valves, Pressure Sensors, Flow Sensor, Conductivity/Temperature Sensors, etc., performing of Factory Acceptance Tests (FATs), and Integration to Customer Distributed Control Systems through OPC-UA and OPC-DA. Doug’s most recent Full-Time position prior to starting his company was at Amgen, where he worked as a Senior Automation Engineer for their Manufacturing Systems through DeltaV, involving programming of all Unit Operations involved for Upstream and Downstream processes, for both Stainless Steel and Single-Use facilities. All roles involved with Automation have also included Creation/Updates of many types of Documentation, such as Specification: User Requirement, Functional, and Design, Wiring Diagrams, Data Flow Diagrams, Commissioning and Qualification (C&Q) Protocols, as well as their Execution, where this Documentation Work involved owning various Drivers, such as: Work Orders, Change Controls, Deviations, and CAPAs (Corrective and Preventative Actions).
Test3
Lead Engineer and Founder
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