Process Engineer- Life Sciences

About Us: BW Design Group is a fully integrated architecture, engineering, construction, system integration, and consulting firm committed to helping our clients realize their most critical goals from Strategy to Commercialization. As the only firm born from a manufacturing technology company to become an independent and fully integrated firm, we combine deep domain expertise in the manufacturing environment with an approach that is built to serve the dynamic needs of our clients. Rooted in our distinct culture of Truly Human Leadership, we cultivate the leaders who will define tomorrow and partner with our clients in the food & beverage, life sciences, industrial, and advanced technology industries to build the future of manufacturing and technology. Barry-Wehmiller is a diversified global supplier of engineering consulting and manufacturing technology for the packaging, corrugating, sheeting and paper-converting industries. By blending people-centric leadership with disciplined operational strategies and purpose-driven growth, Barry-Wehmiller has become a $3 billion organization with nearly 12,000 team members united by a common belief: to use the power of business to build a better world. Job Description: Who You’ll Work With   You will join one of our 45 offices in the US, be part of a committed team of over 1 6 00 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 Engine er (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 role is a key member of the Life Science Team with responsibilities beginning with   initial   client contact, developing early stakeholder (client) alignment based on relationships built on technical competency, proactive client   engagement   and development of innovative   solutions .   You will serve as a   consulting engineer   and technical lead supporting pharmaceutical and biotech clients on   your defined process as mentioned previously . The role will span the entire project lifecycle from basic and detailed design through procurement, construction, commissioning, and startup activities of the systems & equipment that you will be   directly responsible   for.   In addition to working on   these project lifecycle   phases, you will be expected and responsible for performing   technical activities , which would include   supporting one of the following roles :   Aseptic Filling / Finish :   Responsible as   a   System Owner of   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.   Experience within this industry can include filling system supporting equipment, such as Parts Washer, Autoclaves,   Stoppering Systems, Semi-Automated Inspection systems, and Clarified Bulk Tank systems.   Ability to   participate   in system design discussions and workshops with   clients , design-build firm s , and OEM. Ability to develop user requirement specifications, review equipment layouts, and work with OEM directly   on design changes, procurement   activities,   commissioning, startup, and handover. Collaborate with quality and CQV teams on equipment qualification, process validation, and regulatory readiness.   cGMP & Regulatory Compliance:   U nderstanding 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)   Purification :   Responsible as   a   System Owner of Purification systems and processing operations.   Prov ide   technical support to chromatography, filtration, concentration, viral clearance, and bulk drug substance processing systems. Response for   maintai ning   expertise   in regulatory expectations, process technologies, automation advancements, and OEM supplier capabilities while supporting   a capital expansion project through each equipment’s lifecycle.     Prior   experience   supporting one or many of the following systems:   Chromatography Systems  Protein Purification  TFF / UF/DF / Viral Filtration / Depth Filtration Systems  Viral Clearance and Filtration  Process and Buffer Tanks  Bulk Drug Storage Tanks  Single-Use Systems  CIP / SIP Systems  Protein Purification Processes  cGMP & Regulatory Compliance:   U nderstanding of   FDA 21 CFR Parts 210 and 211, FDA Process Validation Guidance, ICH Guidelines ( Q7 through Q12), PDA Technical Reports on Filtration and Bioprocessing, ASME BPE Standards, USP and EU GMP Requirements .     Blood Fractionation :   Responsible as a System Owner of Blood Fractionation systems and processing operations .    Provide technical support for plasma fractionation processes used in   production   of plasma-derived therapies.   Response for   maintaining   expertise   in regulatory