Sr. Process Engineer

Barry-Wehmiller•Raleigh, NC

About The Position

As a Sr. Process Engineer at Design Group, you will join the Architecture/Engineering Process Practice and work with industry experts, technical specialists, and subject matter experts on client life sciences projects. You will support capital projects and implement solutions, working individually and on multidisciplinary teams to help clients improve performance and achieve their goals. The role may include leadership at client sites. You will perform process mechanical design for sterile product manufacturing in the pharmaceutical, biological, and medical device industries. You will execute process system engineering from conceptual planning through final detailed design on projects ranging from system enhancements and unit-operation optimization to greenfield construction. You will collaborate with client Manufacturing, Facilities and Maintenance, Quality, and Validation personnel to ensure designs comply with current Good Manufacturing Practices. The position includes developing process flow diagrams and associated analyses, selecting and specifying equipment, preparing process construction documents, coordinating with controls/automation, utilities, and building systems, and directing CAD designers. You may provide onsite support for testing, start-up, commissioning, and qualification, and help develop project scopes and proposals for engineering/design services and constructed solutions. You will also keep current with emerging technologies and Good Manufacturing Practices. Travel may be required according to 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 valves, instrumentation, and developing functional specifications; ability to work with automation engineers.
Excellent written and oral communication and interpersonal skills, including the 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 by project needs.
A BS degree in Chemical, Mechanical, or Bio Engineering is preferred; other engineering degrees may be considered based on project experience.

Nice To Haves

Familiarity with 3D modeling.
Computer-based hydraulic analysis skills.
Process simulation software skills.
BS degree in Chemical, Mechanical, or Bio Engineering.

Responsibilities

Support capital projects and implement client solutions, individually and as part of project teams.
Work with and guide the process engineering team on life sciences projects; the role may require leadership at client sites.
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, including system enhancements, unit-operation optimization, and greenfield construction.
Work with client Manufacturing, Facilities and Maintenance, Quality, and Validation personnel to ensure systems are designed 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; prepare energy and mass balances; conduct cycle-time and bottleneck analysis; select, size, and specify equipment; and prepare 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 and tie-in lists, installation specifications, bills of material, and scopes of work.
Coordinate with OEMs and vendors to accomplish equipment sizing and selection.
Direct work performed by CAD designers.
Coordinate design with controls/automation, utilities, and building systems.
Provide onsite support as needed during system testing, start-up, commissioning, and qualification.
Develop project scopes and assist with proposals for engineering/design services and complete constructed solutions.
Stay abreast of emerging technologies and current Good Manufacturing Practices.
Travel as necessary for project installation and start-up, client meetings, company-sponsored meetings, training, and industry events.