Process Engineer- Life Sciences

Who You’ll Work With You will join one of our 45 offices in the US, be part of a committed team of over 1600 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 (System Owner), 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. What You’ll Do Design Group is looking for Engineers with 5‑10 years’ experience in one of the following processes: Aseptic Filling / Finish Purification Blood Fractionation The Process Engineer is a key member of the Life Science Team with responsibilities spanning the entire project lifecycle—from initial client contact and stakeholder alignment to detailed design, procurement, construction, commissioning, and startup of the systems & equipment. Technical activities include providing support as a System Owner in the chosen process area and participating in design discussions, workshops, and direct collaboration with OEM and design‑build partners. Aseptic Filling / Finish : System owner responsible for equipment and processes, including filling systems, parts washers, autoclaves, stoppering systems, inspection systems, and bulk tank systems. Activities cover design reviews, procurement, commissioning, startup, handover, and collaboration with quality and CQV teams. Regulatory knowledge of FDA (CFR)/EMA regulations, FDA guidance, ICH guidelines, ISO 13408 & 14644, and PDA technical reports is required. Purification : System owner providing technical support for chromatography, filtration, concentration, viral clearance, and bulk drug substance systems. Expertise in regulatory expectations, process technologies, automation advancements, and OEM supplier capabilities across the equipment lifecycle. Regulatory knowledge of FDA 21 CFR Parts 210 & 211, process validation guidance, ICH Q7‑Q12, PDA technical reports, ASME BPE Standards, USP, and EU GMP requirements. Blood Fractionation : System owner for plasma fractionation processes, supporting ethanol‑based fractionation systems, precipitation tanks, filter presses, intermediate hold tanks, bulk transfer systems, and CIP/SIP systems. Responsibilities include design reviews, procurement, commissioning, startup, and collaboration with quality teams. Regulatory knowledge of FDA 21 CFR Parts 210, 211, 600, & 640, EMA guidance for plasma‑derived medicinal products, ICH Q8‑Q11, ASME BPE standards, USP and EU GMP requirements. What You’ll Bring Minimum of 5 years of pharmaceutical and biologics process system engineering/design experience. Engineering experience in aseptic fill/finish, purification, and/or blood fractionation processes. Working knowledge of process definition means and methods, including identification of process unit operations. Experience with the regulatory standards and guidance listed above. Excellent communication skills, written and oral, interpersonal skills, and the ability to interact with team members and clients. Computer skills including AutoCAD (basic), Microsoft Office, and Microsoft Project (basic). Willing and able to travel as necessary for project requirements. BS degree in Chemical, Mechanical or Bio Engineering is preferred; other engineering degrees considered based on project experience. The approximate pay range for this position is $90,000 - $130,000 per year. This is a good faith estimate at the time of posting. In addition to base compensation, the position is eligible for variable compensation based on performance, in accordance with applicable plans. Final compensation may vary based on factors such as background, knowledge, skills, and geographic location. #J-18808-Ljbffr BW Design Group