Senior Downstream Process Engineer, Commercial - BPG

Thermo Fisher Scientific is a leading company in the healthcare industry, and they are seeking a Senior Downstream Process Engineer to support the design and development of downstream bioprocess solutions for capital projects. This role will involve leading technical initiatives, engaging with customers, and ensuring compliance with regulatory standards.

Responsibilities:

• Lead downstream process design, including PFDs, P&IDs, balances, and equipment specs
• Develop scalable solutions for harvest, clarification, depth filtration, TFF, and chromatography purification systems
• Ensure compliance with cGMP and global regulatory standards
• Lead FEL/FEED efforts, translating customer needs into defined scopes
• Develop costed proposals with scope, assumptions, risks, and exclusions
• Support CAPEX estimates aligned with commercial and margin goals
• Serve as primary technical contact for customers and project teams
• Lead design reviews, technical discussions, and executive presentations
• Collaborate cross-functionally across sales, engineering, and global teams
• Contribute to technical marketing (white papers, webinars, presentations)
• Represent Thermo Fisher at industry events to promote bioproduction solutions
• Ensure smooth handoff to execution teams with clear scope and continuity
• Provide technical guidance during early project phases as needed

Requirements:

• Bachelor's degree in Chemical Engineering, Biochemical Engineering, or related technical field required
• 8+ years of experience in downstream process engineering, purification, or bioprocess system design within the biopharma or life sciences industry
• Strong expertise in downstream processing, including harvest/clarification, depth filtration, tangential flow filtration (TFF), and chromatography (e.g., protein A, ion exchange)
• Experience with capital equipment projects and development of complex engineering proposals
• Demonstrated experience in front-end engineering, process scale-up, and purification process design
• Strong understanding of cGMP and global regulatory requirements (FDA, EMA, ICH)
• Proven ability to collaborate across cross-functional and global teams
• Excellent communication and presentation skills, with experience engaging technical and executive stakeholders
• Ability to manage multiple priorities in a fast-paced, customer-driven environment
• Master's or PhD
• Familiarity with single-use technologies and automation systems (PLC/SCADA, DeltaV)