Senior Process Engineer – Sterile Fill-Finish

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 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:
Design Group is looking for Engineers with significant experience in one of the following processes:

• Aseptic Filling

• Lyophilization

• Visual Inspection

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 aseptic filling, lyophilization, or visual inspection capital projects. 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:

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