Sr Process Engineer

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.

Locations

Brooklyn Park, MN

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

Yes