Sr Process Engineering
Takeda
June 25, 2026
On-site
Brooklyn Park, MN
$89,900 - $141,240 USD yearly
Operations
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About the Role
- Serve as Engineering subject matter expert for 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 reliability/performance; develop solutions to complex problems.
- Lead system qualification, asset management, project execution, and Good Engineering Practices.
- Support site staff development on technical/procedural topics.
How you will contribute
- Create deliverables (PFDs, P&IDs, system and functional specifications).
- Implement modifications under cGMP change control.
- Develop/execute FAT, commissioning, and qualification protocols.
- Develop calibration and preventative maintenance plans.
- Lead deviation investigations and CAPAs.
- Participate in capital planning; manage small–medium projects ($5M or less).
- Interface cross-functionally; troubleshoot; support capacity planning; manage uptime/batch continuity.
What you bring to Takeda
- BS in Engineering; 3+ years relevant experience.
- Pharmaceutical/biotech manufacturing experience; FDA-regulated environment track record.
- Knowledge of fluid mechanics, heat transfer, thermodynamics, mass transfer.
- EIT or Professional Engineer license preferred.
- Experience with commissioning/qualification; bioreactors, centrifugation, chromatography, TFF, CIP, autoclaves, clean utilities, HVAC; instrumentation.
- GMP/regulatory requirements; large capital project experience.
- Preferred: batch control systems, data historians, SQL/scripting; Desirable: automation/PLCs/power/controls; MS Office and MS Project.
Important considerations
- Sedentary work + facility walkdowns, ladder climbing, lift up to 25 lbs, 24/7 on-call, PPE/cleanroom garments, up to ~25% travel.
About the Role
- Serve as Engineering subject matter expert for 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 reliability/performance; develop solutions to complex problems.
- Lead system qualification, asset management, project execution, and Good Engineering Practices.
- Support site staff development on technical/procedural topics.
How you will contribute
- Create deliverables (PFDs, P&IDs, system and functional specifications).
- Implement modifications under cGMP change control.
- Develop/execute FAT, commissioning, and qualification protocols.
- Develop calibration and preventative maintenance plans.
- Lead deviation investigations and CAPAs.
- Participate in capital planning; manage small–medium projects ($5M or less).
- Interface cross-functionally; troubleshoot; support capacity planning; manage uptime/batch continuity.
What you bring to Takeda
- BS in Engineering; 3+ years relevant experience.
- Pharmaceutical/biotech manufacturing experience; FDA-regulated environment track record.
- Knowledge of fluid mechanics, heat transfer, thermodynamics, mass transfer.
- EIT or Professional Engineer license preferred.
- Experience with commissioning/qualification; bioreactors, centrifugation, chromatography, TFF, CIP, autoclaves, clean utilities, HVAC; instrumentation.
- GMP/regulatory requirements; large capital project experience.
- Preferred: batch control systems, data historians, SQL/scripting; Desirable: automation/PLCs/power/controls; MS Office and MS Project.
Important considerations
- Sedentary work + facility walkdowns, ladder climbing, lift up to 25 lbs, 24/7 on-call, PPE/cleanroom garments, up to ~25% travel.