Sr Process Engineer

• 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 including design, installation, qualification, production support, deviation resolution, maintenance, and decommissioning.
• Monitor system reliability and performance.
• Develop and implement 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.

• Develop engineering deliverables including Process Flow Diagrams, P&IDs, System Specifications, and Functional Specifications.
• Implement system modifications under cGMP change control.
• Develop and execute FAT, commissioning protocols, and qualification protocols.
• Develop calibration and preventative maintenance plans.
• Lead deviation investigations and implement corrective and preventative actions.
• Participate in capital planning, spending, and tracking.
• Serve as project manager on small to medium projects under $5M.
• Interface with cross-functional teams to meet project goals.
• Stay current with industry best practices and technologies.
• Complete required training within timeframe.
• Selecting technologies, designing equipment, and diagnosing process issues.
• Making data-driven decisions using engineering principles.
• Ensuring impact to product quality, safety, reliability, and throughput.
• Maintaining regulatory compliance and validation requirements.
• Troubleshooting factory floor issues and supporting capacity planning.
• Managing impact to uptime, batch continuity, and manufacturing schedule.
• Responding to urgency and severity of equipment failures.
• Determining escalation thresholds.
• Balancing short-term mitigation versus long-term solutions.
• Perform other duties as assigned.

• Bachelor’s degree in Engineering
• 3 or more years of relevant experience
• Experience in pharmaceutical or biotechnology manufacturing environment
• Engineer-in-Training (EIT) or Professional Engineer license preferred
• Demonstrated track record supporting process operations and projects in an FDA-regulated environment
• Knowledge of engineering principles including fluid mechanics, heat transfer, thermodynamics, and mass transfer
• Experience applying project management methodologies
• Understanding of commissioning and qualification protocol development
• Direct experience with systems such as bioreactors, centrifugation, chromatography, tangential flow filtration, CIP, autoclaves, clean utilities, and HVAC.
• Familiarity with instrumentation and sensing technologies in pharmaceutical manufacturing
• Experience with regulatory requirements and GMP environments
• Experience supporting large capital projects
• Familiarity with batch control systems, data historians, SQL, and scripting (preferred)
• Knowledge of automation, PLCs, power systems, and controls (desirable)
• Proficient in MS Office (Word, Excel, PowerPoint) and MS Project
• Ability to work in fast-paced, cross-functional teams
• Strong planning, prioritization, and escalation judgment

• At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product.
• Combination of sedentary work and facility walkdowns
• Occasional ladder climbing
• Ability to lift up to 25 lbs.
• Participation in 24/7 on-call rotation
• Use of PPE and clean room garments as required
• Infrequent travel up to approximately 25% during project activities.

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