Sr Process Engineer
Takeda
August 07, 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 a process area (cell culture, harvest, purification, clean-in-place, or utilities systems).
- Ensure systems remain qualified; act as technical owner for design, installation, qualification, production support, deviation resolution, maintenance, and decommissioning.
- Monitor system reliability/performance; develop solutions to complex problems.
- Lead programs for system qualification, asset management, project execution, and Good Engineering Practices.
- Support development of site staff on technical/procedural topics.
How you will contribute
- Develop Process Flow Diagrams, P&IDs, System/Functional Specifications.
- Implement modifications under cGMP change control.
- Develop/execute FAT, commissioning, and qualification protocols.
- Create calibration and preventative maintenance plans.
- Lead deviation investigations and implement CAPA.
- Participate in capital planning; PM small/medium projects under $5M.
- Interface cross-functionally; troubleshoot; manage impact to uptime/batch continuity; respond to equipment failures and define escalation thresholds.
What you bring to Takeda
- Bachelor’s degree in Engineering; 3+ years relevant experience.
- Pharmaceutical/biotech manufacturing experience; FDA-regulated track record.
- EIT or Professional Engineer license preferred.
- Knowledge of fluid mechanics, heat transfer, thermodynamics, and mass transfer.
- Experience with commissioning/qualification, regulatory/GMP environments, and relevant systems (e.g., bioreactors, CIP, clean utilities, HVAC, chromatography, TFF, etc.).
- Preferred: batch control systems, data historians, SQL/scripting; desirable: automation/PLCs/controls.
- Proficient in MS Office and MS Project; strong planning/escalation judgment.
Important Considerations
- Sedentary work + facility walkdowns; occasional ladder climbing; lift up to 25 lbs; 24/7 on-call rotation; PPE/cleanroom garments; infrequent travel up to ~25%.
About The Role
- Serve as Engineering subject matter expert for a process area (cell culture, harvest, purification, clean-in-place, or utilities systems).
- Ensure systems remain qualified; act as technical owner for design, installation, qualification, production support, deviation resolution, maintenance, and decommissioning.
- Monitor system reliability/performance; develop solutions to complex problems.
- Lead programs for system qualification, asset management, project execution, and Good Engineering Practices.
- Support development of site staff on technical/procedural topics.
How you will contribute
- Develop Process Flow Diagrams, P&IDs, System/Functional Specifications.
- Implement modifications under cGMP change control.
- Develop/execute FAT, commissioning, and qualification protocols.
- Create calibration and preventative maintenance plans.
- Lead deviation investigations and implement CAPA.
- Participate in capital planning; PM small/medium projects under $5M.
- Interface cross-functionally; troubleshoot; manage impact to uptime/batch continuity; respond to equipment failures and define escalation thresholds.
What you bring to Takeda
- Bachelor’s degree in Engineering; 3+ years relevant experience.
- Pharmaceutical/biotech manufacturing experience; FDA-regulated track record.
- EIT or Professional Engineer license preferred.
- Knowledge of fluid mechanics, heat transfer, thermodynamics, and mass transfer.
- Experience with commissioning/qualification, regulatory/GMP environments, and relevant systems (e.g., bioreactors, CIP, clean utilities, HVAC, chromatography, TFF, etc.).
- Preferred: batch control systems, data historians, SQL/scripting; desirable: automation/PLCs/controls.
- Proficient in MS Office and MS Project; strong planning/escalation judgment.
Important Considerations
- Sedentary work + facility walkdowns; occasional ladder climbing; lift up to 25 lbs; 24/7 on-call rotation; PPE/cleanroom garments; infrequent travel up to ~25%.