Sr. Process Engineer

Barry-Wehmiller•Raleigh, NC

About The Position

Design Group is seeking a Senior Process Engineer to join its Architecture/Engineering Process Practice. The role supports capital projects and delivers process mechanical design for life sciences clients, including pharmaceutical, biological, and medical device manufacturing. The engineer works independently and with multidisciplinary teams, partners with client personnel and subject matter experts, and may provide leadership at client sites. The position covers process system engineering from conceptual planning through detailed design, on projects ranging from system enhancements and unit-operation optimization to greenfield construction. Work includes designing systems in accordance with current Good Manufacturing Practices, coordinating with automation, utilities, and building-systems teams, and supporting testing, start-up, commissioning, and qualification as needed. The engineer also contributes to project scopes and proposals and directs CAD designers’ work. Design Group describes its culture as people-centered and supportive of professional growth, with mentorship and resources such as its First Year Experience program, Individual Development Plans, and Career Path resources and tools. Travel may be required based on project needs.

Requirements

At least 5 years of pharmaceutical and biologics process system engineering or design experience.
Knowledge and design experience with CIP/SIP, support equipment such as washers, autoclaves, and lyophilizers, and high-purity water systems such as WFI and RODI.
Working knowledge of process definition methods, including identifying required process unit operations.
Experience with FDA and EMA regulatory standards.
Familiarity with process control methodologies, control-valve and instrumentation types, and developing functional specifications; ability to work with automation engineers.
Excellent written and oral communication and interpersonal skills, and ability to interact with team members and clients.
Computer skills including basic AutoCAD, Microsoft Office, and basic Microsoft Project.
Willingness and ability to travel as required for project work.
A BS degree in Chemical, Mechanical, or Bio Engineering is preferred; other engineering degrees may be considered based on actual project experience.

Nice To Haves

Familiarity with 3D modeling.
Skills with computer-based hydraulic analysis and process simulation software.
A BS degree in Chemical, Mechanical, or Bio Engineering.

Responsibilities

Support capital projects and implement solutions for clients, individually and as part of teams.
Guide and work with the process engineering team on life sciences client projects; provide leadership at client sites as needed.
Perform process mechanical design as part of multidisciplinary project teams in an architecture and engineering environment.
Execute process system engineering from conceptual planning through final detailed design across system enhancements, unit-operation optimization, and greenfield construction projects.
Work with client Manufacturing, Facilities and Maintenance, Quality, and Validation personnel to design systems in accordance with current Good Manufacturing Practices.
Design processes and equipment used in sterile product manufacturing for pharmaceutical, biological, and medical device industries.
Develop process flow diagrams, energy and mass balances, cycle-time and bottleneck analyses, equipment selections and specifications, utility requirements matrices, and gap analyses.
Develop process construction documents, including P&IDs, equipment general arrangement drawings, piping plans and orthographic and isometric drawings, access-platform and equipment-support drawings, line lists, tie-in lists, installation specifications, bills of material, and scopes of work.
Coordinate with OEMs and vendors as needed for equipment sizing and selection.
Direct work performed by CAD designers.
Coordinate design with controls and automation, utilities, and building systems.
Provide onsite support as needed during system testing, start-up, commissioning, and qualification.
Develop project scopes and assist in preparing proposals for engineering and design services and constructed solutions.
Stay current with emerging technologies and current Good Manufacturing Practices.
Travel as necessary for project requirements, including installation and start-up activities, client and company meetings, trainings, and industry events.