Job Description

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Job Description

About the role:

The role is responsible for overseeing Fractionation processes by utilizing resources in production while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations which could apply. You are expected to fully participate in both departmental projects and any quality working teams which may be applicable including problem solving in other functional areas as needed. You will fully understands the regulations and may make recommendations according to their interpretations. You are responsible for the successful transfer of new processes/methodologies into the manufacturing area. You will apply corrective and preventive actions to complex situations and mentor others in quality issue prevention. You will assist in managing quality assurance efforts and provide recommendations for improvements. You will conduct independent root cause analysis of process related issues and recommend improvements.

How you will contribute:

• Provide floor-level technical support for manufacturing equipment (setup, changeover, operation support, and troubleshooting).
• Lead and deploy the best practices in the manufacturing organization.
• Diagnose equipment and process upsets using structured problem-solving and implement corrective/preventive actions.
• Partner with Maintenance/Engineering to plan and execute preventive maintenance, critical spares strategy, and reliability improvements.
• Support installation and commissioning activities for new or modified equipment, ensuring readiness for production use.
• Implement and maintain quality control systems to ensure high-quality production.
• Lead continuous improvement initiatives to streamline production processes and reduce waste.
• Monitor and improve process performance (cycle time, yield, scrap/rework, OEE, stability).
• Develop/update process parameters, work instructions, and settings aligned to product and quality requirements.
• Manage, mentor and train a team of production workers, providing direction, support on equipment operation, process parameters, and troubleshooting best practices..
• Prepare production reports and maintain accurate records of production activities.
• Support implementation of change controls, projects and new methodologies to improve production processes.
• Support document revisions, quality investigations and CAPA process.
• Effectively works and communicates with engineers, technicians, managers, and other departments to ensure smooth and seamless production processes.

What you bring to Takeda:

• High school diploma or equivalent required, Bachelors degree in scientific discipline or equivalent certification preferred.
• 4+ years of manufacturing, warehouse, and/or technical office experience, supporting equipment, Maintenance and/or process engineering.
• 2+ years of team leadership or demonstrated experience leading cross-functional teams, preferably including fractionation operations.
• Demonstrated ability to troubleshoot equipment/process issues using data and structured problem-solving.
• Working knowledge of manufacturing KPIs (e.g., OEE, yield, scrap, downtime) and basic statistical tools.
• Ability to work on the production floor and support off-shift/escalation as needed.
• Strong problem-solving and analytical skills are required.
• Strong leadership skills are required.
• Possess knowledge of core manufacturing principles and support systems (Fractionation separation equipment / support systems (WFI / RO / clean steam / compressed gases / HVAC) and facility design.
• Must have excellent organizational, verbal and written communication skills; able to efficiently communicate with cross- functional teams and management on recommended course of action, with minimal assistance.
• Self-driven individual that requires minimal supervision.
• Must have proficient computer skills and be experienced using MS Office software (Word, Excel and PowerPoint).
• Prefer experience in Automation Control Systems, EBM (Electronic batch Record), PI Historian.
• Continuous improvement mindset (Utilize continuous improvement tools to drive positive change in department processes).
• Prefer knowledge of Lean Six-Sigma methodology.

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:

• Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
• Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
• Work in a cold, wet environment.
• Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
• Must be able to lift up to 50 lbs.
• Frequently or constantly to lift, carry push, pull, or move objects and repetitive motions.
• The position requires a combination of sedentary work and walking around the facility.
• Prolonged periods sitting at a desk and working on a computer.
• Ability to work on the manufacturing floor and in production areas for extended periods.
• Subject to inside environmental conditions.
• Travel for this position will include less than 5% locally usually for training purposes.
• Must be able to work off hours as required, during critical operations, deviations, or shutdown/startup activities.
• May be required to enter controlled environments requiring special gowning.

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.

#GMSGQ #ZR1 #LI-MA1

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 job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

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 ]]> <

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