About the role
About the Role:
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
How you will contribute:
- 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
What you bring to Takeda:
- 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
Important Considerations
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. In this role, you may:
- 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
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
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