Senior Process Engineer - Sterile Fill-Finish

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 is shaping 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 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. You will partner with seasoned leaders, technical specialists, and subject matter experts to deliver the highest quality solutions to our clients with consistency and accuracy. Responsibilities Aseptic Filling Responsible as a process expert for Aseptic Filling systems and processing operations, regulatory guidance trends, evolving technology innovations, OEM supplier community partner, with contributions from early design through commissioning and startup activities within the system lifecycle. Prior experience supporting vial and syringe filling lines with integrated isolator and/or RABS systems, CIP & SIP systems, and utility supply to sterile processes. Ability to participate in system design discussions and workshops with client, design‑build firms, and OEM. Firm understanding of aseptic processing and contamination control strategies. Ability to develop user requirement specifications, review equipment layouts, and work with OEM directly on design changes, procurement activities, and commissioning, startup, and handover. Collaborate with quality and CQV teams on equipment qualification, process validation, and regulatory readiness. Experience with high‑potent aseptic processing and BSL categorization is a plus. cGMP & Regulatory Compliance: Deep understanding of FDA (CFR)/EMA regulations (USP, Annex 1), FDA Guidance (Sterile Drug Products Produced by Aseptic Processing, Process Validation), ICH guidelines, ISO 13408 and 14644, PDA Technical Reports (29, 60, 64, and 90). Visual Inspection Responsible as a process expert for Visual Inspection systems, regulatory guidance trends, evolving technology innovations, OEM supplier community partner, with contributions from early design through commissioning and startup activities within the system lifecycle. Prior experience supporting manual, semi‑automated, and automated visual inspection operations with integration into camera‑based vision technologies. Ability to participate in system design discussions and workshops with client, design‑build firm, and OEM. Solid understanding of inspection and defect classification strategy development with sound statistical rationale that meets regulatory standards. Ability to develop user requirement specifications, review equipment layouts, and work with OEM directly on design changes, procurement activities, and commissioning, startup, and handover. Collaborate with quality and CQV teams on equipment qualification, process validation, and regulatory readiness. cGMP & Regulatory Compliance: Deep understanding of FDA (CFR)/EMA regulations (USP 790 and 1790, Annex 1), FDA Guidance (Container Closure Systems for Packaging Human Drugs, Process Validation), ICH guidelines, ISO 13408, PDA Technical Reports (79). Lyophilization Responsible as a process expert for Lyophilization systems, regulatory guidance trends, evolving technology innovations, OEM supplier community partner, with contributions from early design through commissioning and startup activities of process and system lifecycle. Prior experience supporting stand‑alone and fill‑line integrated lyophilizers with loading and unloading systems. Understanding of the technology behind vacuum, refrigeration, and condenser systems and the utilities that are required to supply these support systems. Ability to participate in system design discussions and workshops with client, design‑build firms, and OEM. Ability to develop user requirement specifications, review equipment layouts and process flow diagrams, and work with OEM directly on design changes, procurement activities, and commissioning, startup, and handover. Collaborate with quality and CQV teams on equipment qualification, process validation, and regulatory readiness. cGMP & Regulatory Compliance: Deep understanding of FDA (CFR)/EMA regulations (USP, Annex 1), FDA Guidance (Sterile Drug Products Produced by Aseptic Processing, Process Validation), ICH guidelines, ISO 13408, PDA Technical Reports (29, 64, and 90). Other Activities Included in Each Role 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. 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 OEM’s/vendors as needed to accomplish equipment sizing and selection. Make an impact day‑to‑day with your skills and expertise, strengthening that relationship with our clients and team. What You’ll Bring Minimum of 7 years of pharmaceutical and biologics process system engineering/design experience. Expertise in aseptic filling (vials, syringes), visual inspection, or lyophilization. Working knowledge of process definition means and methods including identifying process unit operations required. Experience with the previously listed regulatory standards and guidance. 5+ years of hands‑on experience reviewing and marking up AutoCAD‑based engineering drawings and working directly with OEMs/vendors through equipment design, fabrication, testing, commissioning, validation, and startup in a fast‑paced capital project environment. Excellent communication skills, written and oral, interpersonal skills and ability to interact with our valued team members and clients. BS degree in Chemical, Mechanical or Bio Engineering is preferred but consideration will be given to other engineering degrees based on actual project experience. Travel Must be able to travel as necessary for project requirements to include but not be limited to: project installation and start‑up activities, client meetings, company‑sponsored meetings, trainings, industry related seminars, forums, or conventions, etc. #J-18808-Ljbffr BW Design Group