Sr. Process Engineer

Barry-Wehmiller • Raleigh, NC

115d

About The Position

BW Design Group is a fully integrated architecture, engineering, construction, system integration, and consulting firm committed to helping our clients realize their most critical goals from Strategy to Commercialization. As the only firm born from a manufacturing technology company to become an independent and fully integrated firm, we combine deep domain expertise in the manufacturing environment with an approach that is built to serve the dynamic needs of our clients. Rooted in our distinct culture of Truly Human Leadership, we cultivate the leaders who will define tomorrow and partner with our clients in the food & beverage, life sciences, industrial, and advanced technology industries to build the future of manufacturing and technology. Barry-Wehmiller is a diversified global supplier of engineering consulting and manufacturing technology for the packaging, corrugating, sheeting and paper-converting industries. By blending people-centric leadership with disciplined operational strategies and purpose-driven growth, Barry-Wehmiller has become a $3 billion organization with nearly 12,000 team members united by a common belief: to use the power of business to build a better world.

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 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.

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.

Benefits

• Professional development resources and mentorships including our First Year Experience program, Individual Development Plans, and Career Path resources and tools.

What This Job Offers

• Career Level: Senior
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees