Principal Process Engineer - Aseptic Fill & Finish

Location: Boxborough

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 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 Principal 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 join our Architecture/Engineering Process Practice and 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 The Principal Process Engineer role is a key member of the Life Science Commercial 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 solution. Principal will lead front end design programming for formulation, sterilization, aseptic processing/filling, and optimized process flow for aseptic processes requiring site survey, space programming and equipment evaluation/selection, economic analysis/justification, risk assessments, and regulatory impact reviews.

In addition to working on front end phases, you will be expected and responsible for performing technical business development active, which would include:
* Participating in DG capabilities presentations to clients
* Contributing to proposal development
* Authoring publications and white papers
* Presenting multiple times per year at industry conferences or networking events Responsible as leading expert for Aseptic processing operations, regulatory guidance trends, evolving technology innovations, OEM supplier community partner, recognized industry expert through published/presented thought leadership and for launching and nurturing lifecycle client programs. Prior responsible charge expertise developing Aseptic facility & process operations by defining concepts, generating client engagement/alignment, evaluating existing processes/operations, defining scale/modality appropriate solutions, aligning integration approach, and providing the qualification strategy for both traditional Aseptic processing methods and emerging technologies to align industry standards with regulatory guidance.

Passionate industry expert with outgoing personality that has experience presenting innovative concepts to other thought leaders, possessing the ability to generate interest, facilitate adoption, and create advocacy for emerging concepts while being cognizant of disruptive technologies and trends that influence investment decisions.
* cGMP & Regulatory Compliance:
Deep understanding of FDA/EMA guidelines (like USP , Annex
1) and managing inspections/deviations.
* Aseptic Processing:
Expertise in sterilization, aseptic filling (cartridges, vials, syringes), sealing, and handling sterile drug products.
* Technology & Equipment:
Mastery of isolators, RABS, VHP decontamination, peristaltic/piston pumps, visual inspection.
* Process Development & Transfer:
Leading tech transfers, optimizing processes, and developing Master Batch Records (MBRs) and SOPs.
* Quality & Contamination Control:
Overseeing environmental monitoring, media fills, gowning,…