Manufacturing Compliance AI & Automation Co-Op

The Manufacturing Compliance AI & Automation Co-op will help design and prototype responsible AI tools that support compliance workflows. 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 risk assessments.

All solutions will operate under established quality, data privacy, information security, validation, and human-review requirements.

• Map current compliance workflows and identify repetitive, document-intensive activities that are appropriate for AI-assisted support.
• Gather user requirements and convert them into clear 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, and 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.

• Gain hands-on experience applying generative AI, automation, and data analytics in a regulated biopharmaceutical manufacturing environment.
• Develop practical knowledge of deviations, CAPAs, change controls, quality risk management, and Good Manufacturing Practice expectations.
• Strengthen skills in product discovery, process mapping, requirements development, prompt design, testing, validation thinking, and responsible AI governance.
• Collaborate with cross-functional stakeholders and practice presenting technical concepts and recommendations to compliance professionals and leadership.
• Build a portfolio of documented prototypes and measurable business outcomes while learning how digital solutions move from concept to controlled implementation.

• This position will be Hybrid (3 days per week onsite) out of the Lexington, Massachusetts location.
• 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.
• Working knowledge of Python, SQL, Microsoft Power Platform, Microsoft Copilot Studio, Azure AI, or similar tools is preferred; equivalent academic or project experience will be considered.
• 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.
• Familiarity with regulated industries, Good Manufacturing Practice, quality systems, or risk management is beneficial but not required.

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