Principal Process Engineer - Aseptic Fill & Finish

Principal, Process Engineering

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You will join one of our 45 offices in the US, be part of a committed team of over 1500 professionals, and work in teams and directly with our clients doing work that shapes the world around us. You will be welcomed into a rapidly growing business and team and empowered to make an impact. You will be valued, cared for, and challenged on your path to becoming a world‑class professional consultant and surrounded by leaders who are committed to creating an environment that enables you to realize your own success and fulfillment.

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.

• High energy and collaborative Process Engineer or Senior Process Engineer who will work with and guide our process engineering team on a broad range of client life sciences projects. This role may require leadership at client sites.
• Process mechanical design as part of multi-discipline project teams in an A&E environment.
• Executes process system engineering from conceptual/planning to final/detail design phase on a wide range of projects from system enhancements or unit operation optimization through all-new greenfield construction.
• Works closely with Client personnel including Manufacturing, Facilities and Maintenance, Quality, and Validation to ensure systems are designed in accordance with current Good Manufacturing Practices.
• Process mechanical design of processes and equipment used in the manufacture of sterile product within the pharmaceutical, biological, and medical device industries.
• Develop process flow diagrams (PFDs) preparing energy and mass balances, conducting cycle time and bottleneck analysis, equipment selection, sizing and specifications, utility requirements matrix, and gap analysis, etc.
• Understanding and development of process construction documents including piping & instrument diagrams (P&IDs), equipment general arrangement drawings, piping plans inclusive of orthographic and isometric drawings, operator access platform and equipment support drawings, line lists, tie‑in lists, installation specifications, bills of material (BOM), scopes of work, etc.
• Interfaces with OEMs/vendors as needed to accomplish equipment sizing and selection.
• Directs the work performed by CAD designers.
• Facilitates design coordination with controls/automation, utilities, and building systems.
• Provides onsite support as needed during system testing, start‑up, commissioning, and qualification.
• Develops project scopes and assists with preparation of proposals for engineering/design services as well as complete constructed solutions.
• Stays 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.

• Minimum of 20 years of pharmaceutical and biologics process system engineering/design experience.
• Knowledge and design experience including CIP/SIP, Support Equipment (Washers, Autoclaves, Lyophilizers), and High Purity Water Systems (WFI and RODI).
• Working knowledge of process definition means and methods including identifying process unit operations required.
• Experience with FDA and EMA regulatory standards.
• Familiar with process control methodologies, types of control valves and instrumentation, developing functional specifications, and comfortable working with automation engineers.
• Excellent communication skills, written and oral, interpersonal skills and ability to interact with our valued team members and clients.
• Computer skills including AutoCAD (basic), Microsoft Office, and Microsoft Project (basic). Familiarity with 3D modeling, computer‑based hydraulic analysis and process simulation software skills are considered a plus.
• Willing…