Process Engineer- Life Sciences
Listed on 2026-07-18
-
Engineering
Quality Engineering, Process Engineer, Validation Engineer
About BW Design Group
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 business, we combine deep domain expertise in the manufacturing environment with an approach that serves the dynamic needs of our clients.
Rooted in a culture of Truly Human Leadership, we partner with clients in the food & beverage, life sciences, industrial, and advanced technology industries to build the future of manufacturing and technology.
As a Process Engineer (System Owner) you will join one of our 45 U.S. offices, working with a committed team of over 1,600 professionals. You will be directly involved with clients, shaping solutions that impact the world. The role is part of the Life Sciences Team, where you will support pharmaceutical and biotech clients across the entire project lifecycle — from initial client contact and early stakeholder alignment through design, procurement, construction, commissioning, and startup of systems and equipment.
Key Responsibilities- Act as the System Owner for one of the following processes:
Aseptic Filling / Finish, Purification, Blood Fractionation. - Develop and maintain process definitions, identify unit operations, and produce early stakeholder alignment.
- Lead technical activities including design, procurement, construction, commissioning, and startup of systems and equipment.
- Collaborate with quality and CQV teams on equipment qualification, process validation, and regulatory readiness.
- Engage with OEMs, design-build firms, and clients on design changes, procurement activities, and handover.
- Provide technical support throughout the equipment lifecycle, ensuring compliance with FDA, EMA, ICH, ISO, and other relevant regulations.
- Travel as required for project installation, startup activities, client meetings, training, and industry events.
- Aseptic Filling / Finish – systems such as Parts Washer, Autoclave, Stoppering Systems, Inspection systems, and Bulk Tank systems; design-build workshops; user requirement specifications; regulatory guidance and innovation.
- Purification – chromatography, filtration, concentration, viral clearance, bulk drug storage, single-use systems; support capital expansion projects; regulatory compliance with FDA 21
CFR Parts
210 and
211 and ICH guidelines. - Blood Fractionation – plasma fractionation processes for plasma‑derived therapies; ethanol‑based fractionation systems, precipitation tanks, filter presses, hold tanks, bulk transfer, and CIP/SIP systems; compliance with FDA 21
CFR Parts,640 and EMA Guidance.
- Minimum of 5 years of process system engineering/design experience in pharmaceutical and biologics processes.
- Engineering experience in aseptic fill/finish, purification, and/or blood fractionation processes.
- Working knowledge of process definition methods, unit operations, and regulatory standards (FDA, EMA, ICH, ISO, ASME).
- Excellent communication, written and oral; strong interpersonal skills; ability to interact with team members and clients.
- Computer skills including basic AutoCAD, Microsoft Office, and Microsoft Project.
- BS degree in Chemical, Mechanical, Bioengineering, or related engineering discipline; other degrees considered based on experience.
- Willingness to travel for project installation, startup, client meetings, training, and industry events.
Approximate pay range: $90,000 - $130,000 per year. In addition to base compensation, the position may qualify for variable compensation based on individual and company performance in accordance with the applicable plan. Final compensation depends on experience, skills, and geographic location.
Benefits and DevelopmentWe offer professional development resources, mentorship, a First‑Year Experience program, Individual Development Plans, and career path resources and tools. The culture of mutual respect, integrity, and entrepreneurial mindset provides a flexible career path.
Equal Employment OpportunityBarry‑Wehmiller is an equal opportunity employer. M/F/D/V. We encourage people from all backgrounds to apply. Please let us know if you require reasonable accommodations during the interview process.
Our organization uses E‑Verify. Applicants may be subject to pre‑employment screening which may include drug screening, reference checks, employment verifications, background screening and/or skills assessments.
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