Process Engineer, Life Sciences (Design Group)

About Us:Design Group operates from more than 45 offices in the United States and India, providing engineering, consulting and technical services for the world's leading companies in the food and beverage, life sciences, advanced technology, industrial and other market sectors. Our nearly 1,500 technical and engineering experts have direct industry experience in industrial automation, control system integration, facility and process engineering, architecture, construction management, regulatory compliance, enterprise technology and other consulting services.

• Design Group is looking for a process engineer, with life science industry experience, technical experience with biopharmaceutical process design for traditional unit operations, that can work collaboratively with as part of our process engineering team on a broad range of life sciences projects. This role requires prior experience in the design, installation, and startup of traditional bioprocess equipment, GXP utility systems, and/or field supervision of trades during construction and commissioning requiring leadership at client sites. This position will work as part of an experienced A+E and Process team responsible project development, strategic planning, engineering design, construction and turnover to Validation in the execution of EPCMV projects.

• Process mechanical design as part of multi-discipline project teams in an A&E environment.
• Executes process system engineering from conceptual/planning to final/detail design phase on a wide range of projects from system enhancements or unit operation optimization through all-new greenfield construction.
• Works closely with Client personnel including Manufacturing, Facilities and Maintenance, Quality, and Validation to ensure systems are designed in accordance with current Good Manufacturing Practices.
• Process mechanical design of processes and equipment used in the manufacture of sterile product within the pharmaceutical, biological and medical device industries.
• Develop process flow diagrams (PFDs) preparing energy and mass balances, conducting cycle time and bottleneck analysis, equipment selection, sizing and specifications, utility requirements matrix, and gap analysis, etc.
• Understanding and development of process construction documents including piping & instrument diagrams (P&IDs), equipment general arrangement drawings, piping plans inclusive of orthographic and isometric drawings, operator access platform and equipment support drawings, line lists, tie-in lists, installation specifications, bills of material (BOM), scopes of work, etc.
• Interfaces with OEM's/vendors as needed to accomplish equipment sizing and selection.
• Directs the work performed by CAD designers.
• Facilitates design coordination with controls/automation, utilities, and building systems.
• Provides onsite support as needed during system installation, testing, start-up, commissioning, and qualification.
• Develops project scopes and assists with preparation of proposals for engineering/design services as well as complete constructed solutions.
• Stays abreast of new and emerging technologies, and current Good Manufacturing Practices

• Minimum of 3 yrs. of relevant biologics, pharmaceutical, biotechnology, or medical device process system engineering/design experience.
• Knowledge and design experience including Upstream/Downstream Processes, Single Use Systems, CIP/SIP, Support Equipment (Washers, Autoclaves, Lyophilizers), and High Purity Water Systems (WFI and RODI).
• Working knowledge of process definition means and methods including identifying process unit operations required
• Experience with FDA and EMA regulatory standards.
• Familiar with process control methodologies, types of control valves and instrumentation, developing functional specifications, and comfortable working with automation engineers.
• Excellent communication skills, written and oral, interpersonal skills and ability to interact with our valued team members and clients.
• Computer skills including AutoCAD (basic), Microsoft Office, and Microsoft Project (basic). Familiarity with 3D modeling, computer-based hydraulic analysis and process simulation software skills are considered a plus.
• Willing and able to travel as necessary for project requirements to include but not be limited to: project installation and start-up activities, client meetings, company sponsored meetings, trainings, industry related seminars, forums, or conventions, etc.

• BS degree in Chemical, Bio Engineering, or Bio Engineering, Mechanical is preferred but consideration will be given to other engineering degrees with commensurate life science industry, consulting, or project experience.