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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, s