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Job Description

Summary

Round Lake is a large-volume pharmaceutical manufacturing facility responsible for filling life-saving plasma-derived therapeutics. Site operations include aseptic filling, inspection, labeling, and packaging.

The Manager, Packaging Performance & Automation is responsible for driving packaging operational excellence through equipment reliability, process optimization, automation initiatives, CAPA effectiveness, deviation reduction, and change control execution. This role serves as the primary business leader for packaging performance and continuous improvement by partnering closely with Engineering, Maintenance, Quality, Validation, and Operations.

The incumbent is responsible for improving equipment effectiveness, increasing throughput, reducing downtime, eliminating recurring process issues, and driving sustainable operational improvements. The individual must leverage data-driven decision-making, lead strategic improvement projects, provide operational and technical coordination for investigations and corrective actions, and support implementation of automation and technology enhancements.

The position is expected to champion Quality Culture, Safety Culture, and Takeda Values while ensuring compliance with cGMP requirements and maintaining a focus on patient, trust, reputation, and business outcomes.

Essential Duties and Responsibilities

• Own packaging performance metrics, including throughput, downtime, OEE, labor efficiency, and quality performance.

• Lead operational excellence initiatives focused on improving packaging efficiency, reliability, quality, and cost performance.

• Drive continuous improvement efforts utilizing Lean Manufacturing, Six Sigma, DMAIC, and problem-solving methodologies.

• Lead and oversee CAPAs, deviations, and change controls to ensure timely execution, effectiveness, and sustainable compliance improvements.

• Partner with Engineering and Maintenance to develop and implement automation, equipment reliability, and technology improvement initiatives.

• Utilize operational data and performance trends to identify opportunities for process optimization and defect reduction.

• Support investigations related to equipment performance, process deviations, recurring defects, and operational disruptions.

• Develop and maintain packaging performance dashboards, KPIs, and management reporting tools.

• Collaborate cross-functionally with Engineering, Maintenance, Quality, Validation, and Operations to execute strategic improvement initiatives.

• Prioritize and support capital projects and equipment enhancements aligned with business and operational objectives.

• Support regulatory inspections and represent packaging operations during internal and external audits.

• Provide coaching and leadership that promotes accountability, innovation, continuous improvement, and operational excellence.

• Champion Takeda Values, Quality Culture, Safety Culture, and patient-focused decision-making.

• Perform other duties as assigned.

Qualifications

• Demonstrated leadership skills with the ability to influence cross-functional teams.

• Strong knowledge of pharmaceutical manufacturing, packaging operations, and cGMP requirements.

• Experience leading CAPAs, deviations, change controls, investigations, and continuous improvement initiatives.

• Understanding of equipment reliability, automation systems, and manufacturing technologies.

• Experience utilizing Lean Manufacturing, Six Sigma, DMAIC, and root cause analysis methodologies.

• Strong analytical, project management, organizational, and problem-solving skills.

• Ability to effectively communicate technical information and operational performance to all organizational levels.

• Proficiency in Microsoft Office applications and manufacturing performance reporting tools.

Education and/or Experience

• Bachelor's degree in Engineering, Science, Manufacturing, Industrial Technology, or a related technical discipline preferred.

• Minimum of 6 years of experience in pharmaceutical, biotechnology, medical device, or regulated manufacturing environments.

• Minimum of 2 years of leadership experience in manufacturing, engineering, maintenance, operational excellence, or packaging operations.

• Demonstrated experience leading CAPAs, deviations, change controls, investigations, and continuous improvement programs.

• Experience supporting automation projects, equipment implementation, or manufacturing technology deployment preferred.

• Experience with packaging equipment, manufacturing systems, and reliability improvement programs preferred.

• Lean Six Sigma Green Belt or equivalent certification preferred.

Physical Demands

• In general, the position requires a combination of sedentary work and routine presence within manufacturing operations to observe processes, equipment performance, and working conditions.

• May require extended periods of walking, standing, attending production meetings, and supporting operational activities in manufacturing environments.

Working Environment

• Must be able to work in controlled manufacturing environments requiring special gowning and PPE.

• Position requires routine interaction with packaging equipment, automated systems, and manufacturing operations.

• May work in clean room, temperature-controlled, and warehouse environments.

• Indoor working conditions.

Other Job Requirements

• Must be able to work non-traditional or extended hours, including weekends and holidays, as needed.

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

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Job Exempt