Sr Process Engineer
Takeda
August 29, 2026
On-site
Brooklyn Park, MN
$89,900 - $141,240 USD yearly
Operations
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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 in a qualified state; act as technical owner across design, installation, qualification, production support, deviation resolution, maintenance, and decommissioning.
- Monitor reliability/performance; develop and implement solutions to complex problems.
- Lead programs for system qualification, asset management, project execution, and Good Engineering Practices; support site staff technical/procedural development.
- Develop engineering deliverables (PFDs, P&IDs, system and functional specifications).
- Implement cGMP change control modifications; develop/execute FAT, commissioning, and qualification protocols.
- Create calibration and preventative maintenance plans; lead deviation investigations and CAPAs.
- Participate in capital planning and manage small/medium projects (<$5M); interface cross-functionally.
Qualifications / Required Skills
- Bachelor’s degree in Engineering; 3+ years relevant experience.
- Pharmaceutical/biotechnology manufacturing experience; FDA-regulated, GMP environment.
- Knowledge of fluid mechanics, heat transfer, thermodynamics, mass transfer.
- Experience with commissioning/qualification protocols and project management methodologies.
Preferred Skills
- EIT or Professional Engineer license; GMP documentation support; experience with bioreactors, centrifugation, chromatography, TFF, CIP, autoclaves, clean utilities, HVAC; instrumentation/sensing; batch control/data historians/SQL/scripting.
- MS Office (Word/Excel/PowerPoint) and MS Project; automation/PLCs/controls (desirable).
Work Requirements
- Sedentary work + facility walkdowns; occasional ladder climbing; lift up to 25 lbs; 24/7 on-call rotation; PPE/cleanroom garments; infrequent travel (~25%).
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 in a qualified state; act as technical owner across design, installation, qualification, production support, deviation resolution, maintenance, and decommissioning.
- Monitor reliability/performance; develop and implement solutions to complex problems.
- Lead programs for system qualification, asset management, project execution, and Good Engineering Practices; support site staff technical/procedural development.
- Develop engineering deliverables (PFDs, P&IDs, system and functional specifications).
- Implement cGMP change control modifications; develop/execute FAT, commissioning, and qualification protocols.
- Create calibration and preventative maintenance plans; lead deviation investigations and CAPAs.
- Participate in capital planning and manage small/medium projects (<$5M); interface cross-functionally.
Qualifications / Required Skills
- Bachelor’s degree in Engineering; 3+ years relevant experience.
- Pharmaceutical/biotechnology manufacturing experience; FDA-regulated, GMP environment.
- Knowledge of fluid mechanics, heat transfer, thermodynamics, mass transfer.
- Experience with commissioning/qualification protocols and project management methodologies.
Preferred Skills
- EIT or Professional Engineer license; GMP documentation support; experience with bioreactors, centrifugation, chromatography, TFF, CIP, autoclaves, clean utilities, HVAC; instrumentation/sensing; batch control/data historians/SQL/scripting.
- MS Office (Word/Excel/PowerPoint) and MS Project; automation/PLCs/controls (desirable).
Work Requirements
- Sedentary work + facility walkdowns; occasional ladder climbing; lift up to 25 lbs; 24/7 on-call rotation; PPE/cleanroom garments; infrequent travel (~25%).