Sr. Process Engineer

Barry-Wehmiller•Raleigh, NC

40d

About The Position

When you join Design Group as a Sr. Process Engineer, you are joining a team that will challenge you and position you for growth. In this role, you will work with a team of industry experts to help the world's leading companies solve their most difficult problems. You will join our Architecture/Engineering Process Practice and partner with seasoned leaders, technical specialists, and subject matter experts to deliver the highest quality solutions to our clients with consistency and accuracy. You'll work individually and in teams to support capital projects and implement solutions for our clients. Together, you will help our clients make critical changes to improve their performance and realize their most important goals.

Requirements

A minimum of ten years of relevant biologics, pharmaceutical, biotechnology, or medical device process system engineering/design experience
Design experience in upstream/downstream processes, single use systems, CIP/SIP, support equipment (washers, autoclaves, lyophilizers), and high purity water systems (WFI, RODI)
Experience in the design, installation, and startup of traditional bioprocess equipment, GXP utility systems, or field supervision of trades during construction and commissioning
A working knowledge of process definition means and methods including identifying process unit operations
An understanding of FDA and EMA regulatory standards
A familiarity with process control methodologies and control valves and instrumentation
Experience developing functional specifications
Excellent written and verbal communication skills and the ability to successfully interact with our team members and clients
Proficiency in AutoCAD (basic), Microsoft Office, and Microsoft Project (basic)
A willingness to travel for project requirements including installation and start-up activities, client and company sponsored meetings, trainings, industry related seminars, forums, and conventions
A bachelor of science in in chemical or mechanical engineering, bioengineering, or a similar engineering degree with applicable life science industry, consulting, or project experience

Nice To Haves

Familiarity with 3D modeling, computer-based hydraulic analysis, and process simulation software (preferred)

Responsibilities

Manage process mechanical design for the manufacturing of sterile products in the pharmaceutical, biological, and medical device industries
Assume responsibility for all phases of project execution including concept/strategic planning, engineering design, construction, and turnover to validation in the execution of EPCMV projects
Execute a wide range of projects including system enhancements/unit operation optimization and greenfield construction
Ensure that manufacturing, facilities and maintenance, quality, and validation systems are designed in accordance with current Good Manufacturing Practices
Develop process flow diagrams (PFDs), prepare energy and mass balance calculations, and conduct cycle time, bottleneck, and gap analyses
Handle equipment selection, sizing, and specifications, and create utility requirement matrices
Develop process construction documents including piping & instrument diagrams (P&IDs) and equipment general arrangement drawings
Create piping plans including orthographic and isometric drawings, operator access platform and equipment support drawings, line lists, tie-in lists, installation specifications, bills of material (BOM), and scopes of work
Direct the work performed by CAD designers
Facilitate design coordination with controls/automation systems, utilities systems, and building systems
Provide on-site support during system installation, testing, start-up, commissioning, and qualification
Develop project scopes and assist with preparation of proposals for engineering/design services
Keep abreast of new and emerging technologies and current Good Manufacturing Practices
Make an impact day-to-day with your skills and expertise, strengthening that relationship with our clients and team