Manufacturing Compliance AI & Automation Co-Op

Takeda•Lexington, MA
•Hybrid

About The Position

The Manufacturing Compliance AI & Automation Co-Op will help design and prototype responsible AI tools that support compliance workflows for the MBO Manufacturing Compliance team. Working with compliance subject matter experts and digital partners, the Co-Op will translate business needs into practical use cases, organize approved content and data, build and test AI agents, and document results. Initial use cases may include deviations, CAPAs, change controls, and quality risk assessments. Solutions will operate under established quality, data privacy, information security, validation, and human-review requirements. The role offers hands-on experience applying generative AI, automation, and data analytics in a regulated biopharmaceutical manufacturing environment. The Co-Op will develop knowledge of compliance and quality processes, strengthen product discovery and responsible AI skills, collaborate with cross-functional stakeholders, and create documented prototypes and measurable business outcomes while learning how digital solutions move from concept to controlled implementation.

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, with 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 translate 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 to communicate 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.

Benefits

  • Paid sick time
  • Civic Duty paid time off
  • Participation in company volunteer events
  • Participation in company-sponsored special events
  • Access to an on-site fitness center where available
  • Monthly commuter subsidy for public transportation or parking
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