Senior Downstream Process Engineer, Commercial
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Job Description
Senior Downstream Process Engineer leading the design and development of bioprocess solutions for capital projects at Thermo Fisher Scientific. Collaborating with global teams and industry leaders for drug substance manufacturing.
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)
- Provide technical guidance during early project phases as needed
Requirements:
- Bachelor’s degree in Chemical Engineering, Biochemical Engineering, or related technical field required; Master’s or PhD preferred
- 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
- Experience with capital equipment projects and development of complex engineering proposals
- Demonstrated experience in front-end engineering, process scale-up, and purification process design
- Familiarity with single-use technologies and automation systems (PLC/SCADA, DeltaV) preferred
- 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.
Benefits:
- Health insurance
- 401(k)
- Paid time off (at least 120 hours)
- 10 paid holidays annually
- Paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave)
- Accident and life insurance
- Short- and long-term disability
- Employee assistance and family support programs
- Commuter benefits
- Tuition reimbursement
- Employees’ Stock Purchase Plan (ESPP)
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