Sr Process Engineer
Takeda
August 07, 2026
On-site
Brooklyn Park, MN
$89,900 - $141,240 USD yearly
Operations
Responsibilities:
- Serve as Engineering subject matter expert for a specific process area (cell culture, harvest, purification, clean-in-place, or utilities systems)
- Ensure systems remain qualified; act as technical owner across design, installation, qualification, production support, deviation resolution, maintenance, and decommissioning
- Monitor system reliability/performance; develop engineering solutions to complex problems
- Lead programs for system qualification, asset management, project execution, and Good Engineering Practices; support technical/procedural site staff development
- Develop engineering deliverables (Process Flow Diagrams, P&IDs, System Specifications, Functional Specifications)
- Implement cGMP change-control modifications; develop/execute FAT, commissioning, and qualification protocols
- Develop calibration/preventative maintenance plans; lead deviation investigations and CAPAs
- Participate in capital planning; serve as PM on small/medium projects (<$5M)
- Troubleshoot equipment/process issues; manage impact to uptime, batch continuity, and schedules; respond to equipment failures
Qualifications & Skills:
- Bachelor’s degree in Engineering; 3+ years relevant experience
- Pharma/biotech manufacturing experience; FDA-regulated environment experience
- Knowledge of fluid mechanics, heat transfer, thermodynamics, mass transfer
- Experience with project management; commissioning/qualification protocol development
- Direct experience with bioreactors, centrifugation, chromatography, TFF, CIP, autoclaves, clean utilities, and HVAC
- Familiarity with instrumentation/sensing, GMP/regulatory requirements; large capital project support
- Preferred: EIT or Professional Engineer license; batch control systems, data historians, SQL/scripting; knowledge of automation/PLCs/controls; MS Office and MS Project; strong planning/prioritization/escalation judgment
Important considerations:
- Sedentary work + facility walkdowns; ladder climbing; lift up to 25 lbs; 24/7 on-call rotation; PPE/cleanroom garments; infrequent travel (~25%).
Application instructions:
- By clicking “Apply,” you understand the employment application process will commence and information will be processed per Takeda’s Privacy Notice and Terms of Use.
- Serve as Engineering subject matter expert for a specific process area (cell culture, harvest, purification, clean-in-place, or utilities systems)
- Ensure systems remain qualified; act as technical owner across design, installation, qualification, production support, deviation resolution, maintenance, and decommissioning
- Monitor system reliability/performance; develop engineering solutions to complex problems
- Lead programs for system qualification, asset management, project execution, and Good Engineering Practices; support technical/procedural site staff development
- Develop engineering deliverables (Process Flow Diagrams, P&IDs, System Specifications, Functional Specifications)
- Implement cGMP change-control modifications; develop/execute FAT, commissioning, and qualification protocols
- Develop calibration/preventative maintenance plans; lead deviation investigations and CAPAs
- Participate in capital planning; serve as PM on small/medium projects (<$5M)
- Troubleshoot equipment/process issues; manage impact to uptime, batch continuity, and schedules; respond to equipment failures
Qualifications & Skills:
- Bachelor’s degree in Engineering; 3+ years relevant experience
- Pharma/biotech manufacturing experience; FDA-regulated environment experience
- Knowledge of fluid mechanics, heat transfer, thermodynamics, mass transfer
- Experience with project management; commissioning/qualification protocol development
- Direct experience with bioreactors, centrifugation, chromatography, TFF, CIP, autoclaves, clean utilities, and HVAC
- Familiarity with instrumentation/sensing, GMP/regulatory requirements; large capital project support
- Preferred: EIT or Professional Engineer license; batch control systems, data historians, SQL/scripting; knowledge of automation/PLCs/controls; MS Office and MS Project; strong planning/prioritization/escalation judgment
Important considerations:
- Sedentary work + facility walkdowns; ladder climbing; lift up to 25 lbs; 24/7 on-call rotation; PPE/cleanroom garments; infrequent travel (~25%).
Application instructions:
- By clicking “Apply,” you understand the employment application process will commence and information will be processed per Takeda’s Privacy Notice and Terms of Use.