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Job Description

About the role:

At Takeda’s Round Lake aseptic fill/finish and Packaging facility, the Associate Director, Process Engineering will lead a cross-functional team responsible for the technical performance, innovation, and lifecycle management of aseptic filling and packaging systems.  This role provides strategic and tactical leadership across multiple production areas and works closely with Manufacturing, Maintenance, Automation, Reliability, Validation, Manufacturing Science, Quality, Business Excellence and Supply Chain to ensure operational excellence and regulatory compliance.  You will lead and support capital improvement initiatives, drive root cause investigations, and foster a culture of collaboration, accountability, and continuous improvement.

How you will contribute:

Leadership & Strategy

• Own and execute the engineering strategy for aseptic filling and packaging systems to ensure reliable performance, compliance, and future capacity growth.

• Provide direction, coaching, and performance management to a team of Principal and Senior Engineers.

• Serve as a key member of the Engineering Leadership Team, supporting site-level strategic planning and execution.
• Manage and forecast capital and expense budgets related to process engineering activities and projects.
• Guide risk assessments related to critical systems and ensure redundancy strategies are in place to mitigate production disruptions.

Process and Packaging Oversight

• Provide expert-level technical guidance on aseptic filling processes, packaging technologies, and automated systems (e.g., serialization, vision inspection).

• Drive implementation of Good Engineering Practices (GEP) and standardized methodologies for project delivery, work order management, and asset lifecycle management.

• Oversee equipment lifecycle strategies, process improvements, and optimization projects for line performance and solution yield.

• Act as the escalation point for complex equipment and process deviations impacting production.

Cross-Functional Collaboration

• Drive alignment with Capital Projects, Validation, Reliability Engineering, and Maintenance to ensure efficient execution of technical initiatives.

• Provide technical leadership and process engineering support across Round Lake and to external sites when needed.

• Serve as the Engineering primary liaison with Regulatory Affairs, and QA during inspections and regulatory submissions.

• Support deviation investigations, CAPAs, change controls, and risk assessments across technical systems.

Operational Excellence

• Champion initiatives that improve OEE, and enhance operator/machine interface efficiency.

• Ensure effective execution of change controls, non-conformances, CAPAs, and technical documentation for GMP systems.

• Drive a proactive culture of safety, compliance, and engineering excellence.

What you bring to Takeda:

• Bachelor’s degree in Mechanical, Electrical, Chemical, or related engineering field with 8+ year of experience within GMP manufacturing (3+ years in management)

• Experienced in leading engineering teams in GMP environments, supporting aseptic fill, inspection, and packaging.

• Technical expertise in utility systems like CIP/SIP, WFI, RO/DI, clean steam, and HVAC for sterile manufacturing.

• Knowledgeable in automated fill/finish equipment, packaging lines, serialization, and vision inspection technologies.

• Proven ability to troubleshoot, optimize processes, and improve performance in complex manufacturing systems.

• Skilled in coaching engineers and fostering accountability, learning, and technical growth.

• Effective collaborator with cross-functional teams to meet operational and compliance goals.

• Well-versed in FDA/global regulatory requirements; experienced in audits and inspections.

• Strategic planner who translates priorities into actionable technical roadmaps.

• Decisive leader with a focus on reliability and quality while handling competing priorities.

• Strong communicator with excellent organizational and stakeholder management skills.

• Experienced in assessing risks, continuity planning, and implementing redundancy for critical systems.

• Familiar with project portfolio management and maintenance tools (e.g., JDE, Maximo, SAP, MS Project).

What Takeda can offer you:

• Comprehensive Healthcare: Medical, Dental, and Vision

• Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan

• Health & Wellness programs including onsite flu shots and health screenings

• Generous time off for vacation and the option to purchase additional vacation days

• Community Outreach Programs and company match of charitable contributions

• Family Planning Support

• Flexible Work Paths

• Tuition reimbursement

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.

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.

This posting excludes Colorado applicants.

Empowering our people to shine:

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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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.

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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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