Sr Process Engineer
Takeda
June 25, 2026
On-site
Brooklyn Park, MN
$89,900 - $141,240 USD yearly
Operations
About the Role
- Serve as the Engineering subject matter expert for a specific process area (cell culture, harvest, purification, clean-in-place, or utilities systems)
- Ensure systems remain in a qualified state; act as technical owner for system lifecycle (design, installation, qualification, production support, deviation resolution, maintenance, decommissioning)
- Monitor system reliability and performance; develop engineering solutions to complex problems
- Lead programs related to system qualification, asset management, project execution, and Good Engineering Practices
- Support development of site staff on technical and procedural topics
How you will contribute
- Develop engineering deliverables (Process Flow Diagrams, P&IDs, System Specifications, Functional Specifications)
- Implement system modifications under cGMP change control
- Develop/execute FAT, commissioning, and qualification protocols
- Develop calibration and preventative maintenance plans
- Lead deviation investigations; implement corrective/preventative actions
- Participate in capital planning; serve as PM on small–medium projects (<$5M)
- Troubleshoot factory floor issues; support capacity planning
- Manage impact to uptime, batch continuity, and manufacturing schedule; respond to equipment failures; determine escalation thresholds; balance mitigation vs. long-term solutions
What you bring
- Bachelor’s degree in Engineering
- 3+ years relevant experience
- Pharma/biotech manufacturing experience; FDA-regulated environment experience
- EIT or Professional Engineer license preferred
- Knowledge of fluid mechanics, heat transfer, thermodynamics, and mass transfer
- Experience with project management; commissioning/qualification protocol development
- Direct experience with bioreactors, centrifugation, chromatography, TFF, CIP, autoclaves, clean utilities, HVAC
- GMP/regulatory compliance experience; instrumentation/sensing familiarity
- Preferred: batch control systems, data historians, SQL, scripting; Desirable: automation/PLCs/power systems/controls
- Proficient: MS Office and MS Project; strong planning/prioritization/escalation judgment
Important Considerations
- Sedentary work + facility walkdowns; occasional ladder climbing; lift up to 25 lbs; 24/7 on-call; PPE/clean room garments; infrequent travel (~25%)
Compensation/Benefits (if provided)
- US base salary range: $89,900.00–$141,240.00
- May include incentives and benefits such as medical/dental/vision, 401(k) match, disability, life insurance, tuition reimbursement, volunteer time off, holidays, well-being benefits; up to 80 hours sick time and up to 120 hours paid vacation for new hires
Application instructions
- Apply via the “Apply” button; employment application process starts upon submission, and information is processed per the employer’s Privacy Notice/Terms of Use.
- Serve as the Engineering subject matter expert for a specific process area (cell culture, harvest, purification, clean-in-place, or utilities systems)
- Ensure systems remain in a qualified state; act as technical owner for system lifecycle (design, installation, qualification, production support, deviation resolution, maintenance, decommissioning)
- Monitor system reliability and performance; develop engineering solutions to complex problems
- Lead programs related to system qualification, asset management, project execution, and Good Engineering Practices
- Support development of site staff on technical and procedural topics
How you will contribute
- Develop engineering deliverables (Process Flow Diagrams, P&IDs, System Specifications, Functional Specifications)
- Implement system modifications under cGMP change control
- Develop/execute FAT, commissioning, and qualification protocols
- Develop calibration and preventative maintenance plans
- Lead deviation investigations; implement corrective/preventative actions
- Participate in capital planning; serve as PM on small–medium projects (<$5M)
- Troubleshoot factory floor issues; support capacity planning
- Manage impact to uptime, batch continuity, and manufacturing schedule; respond to equipment failures; determine escalation thresholds; balance mitigation vs. long-term solutions
What you bring
- Bachelor’s degree in Engineering
- 3+ years relevant experience
- Pharma/biotech manufacturing experience; FDA-regulated environment experience
- EIT or Professional Engineer license preferred
- Knowledge of fluid mechanics, heat transfer, thermodynamics, and mass transfer
- Experience with project management; commissioning/qualification protocol development
- Direct experience with bioreactors, centrifugation, chromatography, TFF, CIP, autoclaves, clean utilities, HVAC
- GMP/regulatory compliance experience; instrumentation/sensing familiarity
- Preferred: batch control systems, data historians, SQL, scripting; Desirable: automation/PLCs/power systems/controls
- Proficient: MS Office and MS Project; strong planning/prioritization/escalation judgment
Important Considerations
- Sedentary work + facility walkdowns; occasional ladder climbing; lift up to 25 lbs; 24/7 on-call; PPE/clean room garments; infrequent travel (~25%)
Compensation/Benefits (if provided)
- US base salary range: $89,900.00–$141,240.00
- May include incentives and benefits such as medical/dental/vision, 401(k) match, disability, life insurance, tuition reimbursement, volunteer time off, holidays, well-being benefits; up to 80 hours sick time and up to 120 hours paid vacation for new hires
Application instructions
- Apply via the “Apply” button; employment application process starts upon submission, and information is processed per the employer’s Privacy Notice/Terms of Use.