Design Group
Life Sciences
SeniorProcessEngineer–SterileFill-Finish
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“Senior Process Engineer – Sterile Fill-Finish at Design Group. Skills: Aseptic Filling, Lyophilization, Visual Inspection. Serve as consulting engineer. Support pharmaceutical and biotech clients”
What You'll Achieve.
Deliver the highest quality solutions to our clients with consistency and accuracy; Make an impact day-to-day with your skills and expertise
Industry & Context.
Solve their most difficult problems
Must be able to travel as necessary for project requirements, Pre-employment screening
What They're Looking For.
Must Have
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, 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), FDA (CFR)/EMA regulations (USP 790 and 1790, Annex 1), FDA Guidance (Container Closure Systems for Packaging Human Drugs, Process Validation), PDA Technical Reports (79), FDA (CFR)/EMA regulations (USP, Annex 1), PDA Technical Reports (29, 64, and 90)
Nice to Have
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), 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), 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), Experience with high-potent aseptic processing and BSL categorization is a plus
What You'll Do.
Serve as consulting engineer
Support pharmaceutical and biotech clients
Manage entire project lifecycle
Perform technical activities
Execute process system engineering
Design systems in accordance with GMP
Develop process construction documents
Interface with OEMs/vendors
How You'll Work.
Team & Collaboration
Work with a team of industry experts; Partner with seasoned leaders; Collaborate with quality and CQV teams; Work closely with Client personnel; Interact with our valued team members and clients; Surrounded by exceptional talent
Communication Scope
Excellent communication skills; Written communication skills; Oral communication skills; Interpersonal skills
Process & Methodology
Capital projects
Full Job Description
**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:** 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 solv
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