Manufacturing Investigation, Principal Analyst
Takeda
August 29, 2026
On-site
Libertyville, IL
$103,500 - $162,690 USD yearly
Operations
About the role:
As a Manufacturing Investigation Principal Analyst, you will lead the investigation and resolution of product and process deviations to ensure the quality, compliance, and reliability of manufacturing operations. You will act as a subject matter expert in deviation management, partnering cross-functionally with Manufacturing, Quality, Engineering, and Supply Chain to identify root causes, drive corrective and preventive actions (CAPAs), and continuously improve manufacturing processes.
How you will contribute:
- Lead and coordinate investigations of manufacturing and product deviations within the Quality Management System.
- Perform trend analysis on deviations and quality events to identify recurring issues and process improvement opportunities.
- Conduct root cause analysis and ensure effective CAPA implementation.
- Maintain and continuously improve deviation investigation procedures and related quality processes.
- Provide technical expertise and guidance on investigation methodologies and compliance requirements.
- Partner with stakeholders to ensure timely communication, escalation, and resolution of quality events.
- Support inspection readiness and responses to regulatory observations as required.
- Participate in continuous improvement; occasionally lead small projects or mentor junior colleagues.
What you bring to Takeda:
- Bachelor’s degree in Life Sciences, Biotechnology, Pharmacy, Engineering, or related scientific discipline (required).
- Several years of GMP-regulated pharmaceutical/biotechnology/biologics manufacturing experience.
- Demonstrated experience leading deviation investigations, root cause analysis, and CAPA management.
- Strong GMP and pharmaceutical quality systems knowledge.
- Experience with quality management systems and investigation workflows in regulated environments.
- Ability to identify process weaknesses and implement sustainable improvements.
- Excellent technical writing, communication, and stakeholder management skills.
- Ability to work independently and manage competing priorities.
Application instructions:
By clicking the “Apply” button, you acknowledge the employment application process will commence and your information will be processed per Takeda’s Privacy Notice and Terms of Use; you attest the submitted information is true to the best of your knowledge.
As a Manufacturing Investigation Principal Analyst, you will lead the investigation and resolution of product and process deviations to ensure the quality, compliance, and reliability of manufacturing operations. You will act as a subject matter expert in deviation management, partnering cross-functionally with Manufacturing, Quality, Engineering, and Supply Chain to identify root causes, drive corrective and preventive actions (CAPAs), and continuously improve manufacturing processes.
How you will contribute:
- Lead and coordinate investigations of manufacturing and product deviations within the Quality Management System.
- Perform trend analysis on deviations and quality events to identify recurring issues and process improvement opportunities.
- Conduct root cause analysis and ensure effective CAPA implementation.
- Maintain and continuously improve deviation investigation procedures and related quality processes.
- Provide technical expertise and guidance on investigation methodologies and compliance requirements.
- Partner with stakeholders to ensure timely communication, escalation, and resolution of quality events.
- Support inspection readiness and responses to regulatory observations as required.
- Participate in continuous improvement; occasionally lead small projects or mentor junior colleagues.
What you bring to Takeda:
- Bachelor’s degree in Life Sciences, Biotechnology, Pharmacy, Engineering, or related scientific discipline (required).
- Several years of GMP-regulated pharmaceutical/biotechnology/biologics manufacturing experience.
- Demonstrated experience leading deviation investigations, root cause analysis, and CAPA management.
- Strong GMP and pharmaceutical quality systems knowledge.
- Experience with quality management systems and investigation workflows in regulated environments.
- Ability to identify process weaknesses and implement sustainable improvements.
- Excellent technical writing, communication, and stakeholder management skills.
- Ability to work independently and manage competing priorities.
Application instructions:
By clicking the “Apply” button, you acknowledge the employment application process will commence and your information will be processed per Takeda’s Privacy Notice and Terms of Use; you attest the submitted information is true to the best of your knowledge.