Process Engineer

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Serve as the Engineering subject matter expert for a specific process area (cell culture harvest purification clean-in-place or clean/facility utilities systems) ensuring systems remain in a qualified state. Act as the technical owner for the system lifecycle including equipment design and installation qualification production support deviation resolution maintenance and decommissioning. Monitor system reliability and performance to ensure operational excellence. Develop evaluate and implement engineering solutions to complex technical challenges. Support senior engineers in developing and implementing programs related to system qualification asset management project execution and Good Engineering Practices (GEP).

• Develop engineering deliverables including Process Flow Diagrams (PFDs) Piping & Instrumentation Diagrams (P&IDs) System Specifications and Functional Specifications.
• Implement system modifications through cGMP change control processes.
• Develop and execute Factory Acceptance Tests (FAT) commissioning protocols and qualification protocols.
• Develop robust calibration and preventive maintenance strategies.
• Lead investigations into system deviations and implement corrective and preventive actions (CAPAs).
• Stay current with biopharmaceutical industry best practices and emerging technologies.
• May serve as Project Manager on small capital projects (less than $1M).
• Partner with cross-functional teams to successfully execute engineering initiatives.
• Complete required training within established timelines.
• Perform other duties as assigned.

• Bachelors degree in Engineering is required.
• 0 or more years of engineering or related experience with increasing responsibilities is required.
• Experience working in a pharmaceutical or biotechnology regulated manufacturing environment is strongly preferred.
• A Chemical Engineering degree is preferred.
• Engineer-in-Training (EIT) certification or a Professional Engineer (PE) license is preferred.
• Experience working in an FDA-regulated industry utilizing current Good Manufacturing Practices (cGMP) is strongly preferred.
• Working knowledge of core engineering principles including fluid mechanics heat transfer thermodynamics and mass transfer is preferred.
• Familiarity with the operation support or design of bioreactors centrifugation chromatography tangential flow filtration (TFF) Clean-in-Place (CIP) systems autoclaves clean utilities or HVAC systems is preferred.
• Basic knowledge of process automation programmable logic controllers (PLCs) instrumentation and controls is highly desirable.
• Proficiency with Microsoft Office applications (Word Excel PowerPoint) and Microsoft Project is required.
• Ability to work effectively in a fast-paced team-oriented cross-functional environment is required.
• Strong planning prioritization and organizational skills including knowing when to escalate issues are required.

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 this role you may:

• In general the position requires a combination of sedentary work and walking throughout the facility.
• May occasionally climb ladders.
• May be required to lift up to 25lbs.
• Requires participation in 24/7 on-call support rotation with other automation and process engineering personnel.
• May occasionally be required to wear personal protective equipment (PPE) and other clean room garments. This may include safety shoes safety glasses aprons face shields lab coats full body gowns booties hair nets and gloves and hearing protection. Removal of makeup and jewelry would also be required at times.
• Infrequent travel but may approach 25% during project activities.

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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Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees and we strive to be more transparent with our pay practices.

For Location:

U.S. Base Salary Range:

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors including the qualifications of the individual applicant for the position years of relevant experience specific and unique skills level of education attained certifications or other professional licenses held and the location in which the applicant lives and/or from which they will be performing the actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

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EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race color religion sex sexual orientation gender identity gender expression parental status national origin age disability citizenship status genetic information or characteristics marital status status as a Vietnam era veteran special disabled veteran or other protected veteran in accordance with applicable federal state and local laws and any other characteristic protected by law.

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