Manufacturing Compliance AI & Automation Co-Op

Takeda Pharmaceutical Co.; Lexington (MA); Hybrid; USD 29,000 - 63,000; Part time

Benefits offered by this job

Paid sick time

Civic Duty paid time off

Participation at company volunteer to/

Participation at company sponsored spe

Access to on-site fitness center (on‑s

Commuter Benefit: transit or parking

Job summary

Takeda Pharmaceutical Co. in Lexington, MA, is seeking a Manufacturing Compliance AI & Automation Co-op to design and prototype responsible AI tools that support compliance workflows.

You will translate business needs into use cases, assemble content and data, build AI agents, and document results within quality and privacy requirements. As a Co-op, you will gain hands-on experience applying generative AI and data analytics in a regulated biopharma setting, with exposure to deviations, CAPAs,

Qualifications

• Pursuing a Bachelor’s or Master’s degree in a relevant field (see above).
• Interest in generative AI, ML, automation, data analytics, or digital product development.
• Working knowledge of Python, SQL, Microsoft Power Platform, Copilot Studio, Azure AI or equivalent.

Responsibilities

• Map current compliance workflows and identify repetitive, document-intensive activities that AI can support.
• Translate requirements into clear use cases, user stories, and acceptance criteria.
• Develop and test proof-of-concept AI agents for deviations, CAPA checks, change controls, and risk prep.
• Prepare and curate knowledge sources, prompts, and test scenarios while protecting confidential information.
• Evaluate outputs for accuracy, traceability, usability, bias, and compliance risk; document defects and needed human review.
• Build simple dashboards to communicate pilot performance and improvement opportunities.
• Create user guides, governance recommendations, and a final handoff presentation to the Manufacturing Compliance team.

Skills

Generative AI

Machine Learning

Process Automation

Data Analytics

Digital Product Development

Education

Bachelor's or Master's in Computer Science/Data Science/AI/IS/Engineering/Bioengineering/Life Sciences

Tools

Python

SQL

Microsoft Power Platform

Microsoft Copilot Studio

Azure AI

Job description

Role Overview

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.

How You Will Contribute

• 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.

Co-op Development Opportunities

• 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.

Job Requirements

• 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.

Takeda Compensation and Benefits Summary

We understand compensation may bean important factoras you consider an internship opportunity. We are committed toequitablepay for all employees, and we strive to be more transparent with our pay practices. For Location: USA - MA - Lexington - BIO OPS U.S. Hourly Wage Range: $21.00 - $46.00 The estimated hourly range reflectsan anticipatedrange for this position. The actual hourly wage offered will depend on the candidate’s school year/level to be entered following completion of internship. The actual hourly wage offered will bein accordance withstate or local minimum wage requirements for the job location.

• Paid sick time
• Civic Duty paid time off
• Participation at company volunteer events
• Participation at company sponsored special events
• Access to on-site fitness center (where available)
• Commuter Benefit: To offset your work-commute expenses, Takeda provides U.S. employees with a fixed monthly subsidy to be used for either public transportation (transit) or parking.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations USA - MA - Lexington - BIO OPS

Worker Type Employee Worker Sub-Type Paid Intern (duración determinada) (en formación) Time Type Full time

Job Exempt No

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own. Takeda is an equal opportunity employer.

For applicants of U.S. and Puerto Rico positions:

Our commitment to Equal Employment Opportunity (EEO).

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