Manufacturing Compliance AI & Automation Co-Op

Takeda•Lexington, MA

2d•$21 - $46•Hybrid

About The Position

The MBO Manufacturing Compliance team supports manufacturing operations by strengthening the quality and compliance systems used to manage deviations, corrective and preventive actions (CAPAs), change controls, and quality risk assessments. The team works with Manufacturing, Quality, Engineering, Digital, and other site functions to improve investigation quality, enable risk-based decisions, support inspection readiness, and drive sustainable compliance improvements. The Manufacturing Compliance AI & Automation Co-op will help design and prototype responsible AI tools for compliance workflows. In partnership with compliance subject matter experts and digital teams, the Co-op will translate business needs into practical use cases, organize approved content and data, build and test AI agents, and document results. Potential initial use cases include deviations, CAPAs, change controls, and risk assessments. Solutions must follow established quality, data privacy, information security, validation, and human-review requirements. This is a hybrid, full-time paid co-op/internship based in Lexington, Massachusetts, with three onsite days per week. The role offers hands-on experience with generative AI, automation, and data analytics in regulated biopharmaceutical manufacturing, as well as opportunities to develop skills in compliance processes, product discovery, process mapping, requirements development, prompt design, testing, validation thinking, and responsible AI governance.

Requirements

Must be pursuing a Bachelor's or Master's degree in Computer Science, Data Science, Artificial Intelligence, Information Systems, Engineering, Bioengineering, Life Sciences, or a related field.
Interest in generative AI, machine learning, process automation, data analytics, or digital product development.
Strong analytical, problem-solving, documentation, and communication skills, including the ability to convert ambiguous needs into structured requirements.
Ability to work carefully with confidential information and follow data privacy, information security, and quality-system requirements.
Ability to collaborate with technical and non-technical stakeholders and incorporate feedback through iterative testing.

Nice To Haves

Working knowledge of Python, SQL, Microsoft Power Platform, Microsoft Copilot Studio, Azure AI, or similar tools; equivalent academic or project experience will be considered.
Familiarity with regulated industries, Good Manufacturing Practice, quality systems, or risk management.

Responsibilities

Map current compliance workflows and identify repetitive, document-intensive activities suitable for AI-assisted support.
Gather user requirements and turn them into use cases, user stories, acceptance criteria, and process maps.
Develop and test proof-of-concept AI agents for deviation investigation support, CAPA quality checks, change control impact assessment, and quality risk assessment preparation.
Prepare and curate approved knowledge sources, example records, prompts, and test scenarios while protecting confidential and regulated information.
Evaluate outputs for accuracy, traceability, usability, bias, and compliance risk; document defects, limitations, and required human review.
Build simple dashboards or summaries communicating pilot performance, user feedback, cycle-time observations, and recommended improvements.
Create user guides, technical documentation, governance recommendations, and a final presentation to support a sustainable handoff to the MBO Manufacturing Compliance team.
Collaborate with cross-functional stakeholders and incorporate feedback through iterative testing.
Present technical concepts and recommendations to compliance professionals and leadership.