Principal Process Engineer – API + OSD

Join to apply for the Principal Process Engineer – API + OSD role at BW Design Group

The Principal Process Engineer will join the Architecture/Engineering Process Practice, partnering with senior leaders and technical experts to deliver high‑quality solutions for life science clients. You will work with teams across our offices and directly with our clients to shape projects in the pharmaceutical and biologics space.

• Lead front end design programming for API and/or OSD processes, including site survey, space programming, equipment evaluation/selection, economic analysis/justification, risk assessments, and regulatory impact reviews.
• Engage in technical business development activities: participate in capabilities presentations to clients, contribute to proposal development, author publications and white papers, and present at industry conferences or networking events.
• Act as the leading expert for API and/or OSD processing operations, regulatory guidance trends, evolving technology innovations, and lifecycle client programs.
• Develop concepts for API/OSD processes, define client engagement and alignment, evaluate existing processes, determine scale/modality solutions, and provide qualification strategies aligned with regulatory guidance.
• Deliver training and leadership, and execute process system engineering from conceptual planning to final design across projects from enhancements to greenfield construction.
• Prepare process construction documents (P&IDs, equipment drawings, BOMs, scopes of work) and interface with OEMs/vendors for sizing and selection of equipment.
• Develop project scopes and assist with proposals for engineering/design services and complete constructed solutions.
• Stay abreast of new and emerging technologies and current Good Manufacturing Practices.

• Minimum of 20 years of pharmaceutical and biologics process system engineering/design experience.
• Experience in proposal generation and business development.
• Front-end/feasibility study experience.
• Expertise in sterilization, aseptic filling (cartridges, vials, syringes), sealing, and handling sterile drug products.
• Working knowledge of process definition means and methods including identifying process unit operations required.
• Experience with FDA and EMA regulatory standards.
• Excellent communication skills, written and oral, and interpersonal skills.
• Computer skills including AutoCAD (basic), Microsoft Office, and Microsoft Project (basic); familiarity with 3D modeling, hydraulic analysis and process simulation software is a plus.
• Willing and able to travel for project requirements.
• BS degree in Chemical, Mechanical or Bio Engineering is preferred, but consideration will be given to other engineering degrees based on project experience.

Our culture and commitment to our people is what sets us apart. We foster an environment of mutual respect, integrity, and growth. As a Principal Process Engineer, you will build a meaningful and fulfilling career with professional development resources and mentorships including our First Year Experience program, Individual Development Plans, and Career Path resources and tools.

The approximate pay range for this position is $250K - $275K. Final compensation may vary based on background, knowledge, skills, abilities, and geographic location.

• Associate

• Full-time

• Management and Manufacturing