
Sr. Process Engineer
- Raleigh, NC
- Permanent
- Full-time
- 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
- 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)
- Familiarity with 3D modeling, computer-based hydraulic analysis, and process simulation software (preferred)
- 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