MES Recipe Author Associate

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work, but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

About Lilly

At Lilly, everything we do starts with patients. We unite caring with discovery to make life better for people around the world. Headquartered in Indianapolis, Indiana, our global team of over 50,000 employees work with urgency and purpose to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. We bring our best to this work because people depend on it. If you're driven by purpose and determined to make a meaningful difference for patients, we invite you to bring your skill and your commitment to Lilly.

About Technology@Lilly

At Lilly, technology is not a support function. It is how a global medicine company operates, innovates, and delivers. Lilly in Hyderabad builds the capabilities that make this possible, cloud platforms, AI systems, and automation at enterprise scale, all in service of a purpose that makes this technology work genuinely distinctive, from advancing drug discovery to enabling connected clinical trials to keeping a global medicine company running at the standard patients deserve.

About the Business Function:

From molecule to market, Global Manufacturing plays an important role in every step along a product’s lifecycle. Most of our customers never see the scientific and technical resources behind our medicines. But customers experience, every day, the performance of our high-quality products and global supply network.

Global Manufacturing comprises a core group of functions that contribute to the production and supply of high-quality products: Engineering; Manufacturing Information & Control Systems; Quality & Labs, Technology Services/Manufacturing Science; Global Health, Safety and Environment; and Global Supply Chain.

About the Role

We are looking for an experienced MES professional to join our MES deployment team, responsible for recipe authoring, validation, and production support across manufacturing sites. The role requires strong hands-on expertise in MES platforms (PharmaSuite or Werum PAS-X) and a solid understanding of GMP-regulated manufacturing processes.

Key Responsibilities

Author, configure, and maintain MES recipes, including Generic Master Batch Records (GMBR) and Production Master Batch Records (PMBR), on PharmaSuite or Werum PAS-X platforms

Support MES recipes in production, including troubleshooting, making changes, and ensuring recipe integrity during live operations

Manage recipe migration and promotion across environments (Dev → Test/QA → Validation → Production) following change control processes

Perform end-to-end recipe validation, including test script authoring, execution, and documentation in line with GxP/CSV requirements

Collaborate with cross-functional MES deployment engineers to plan and execute recipe releases and site go-lives

Provide L2/L3 support for recipe-related incidents, performing root cause analysis and implementing corrective/preventive actions

Ensure all recipe changes comply with data integrity (ALCOA+), 21 CFR Part 11, and Annex 11 requirements

Partner with Manufacturing, Quality, and Validation teams to align recipe design with process and compliance needs

Maintain accurate documentation for authored/modified recipes, including change records and test evidence

Required Skills & Experience

3–5 years of experience in MES recipe authoring and support

Hands-on experience with PharmaSuite or Werum PAS-X MES platforms

Practical exposure to GMBR and PMBR authoring and lifecycle management

Experience moving/deploying recipes across multiple environments

Working knowledge of recipe/system validation practices (IQ/OQ/PQ, test scripting)

Experience in a production support role (L2/L3) within a regulated manufacturing environment

Understanding of GxP, CSV/GAMP 5, and pharmaceutical manufacturing quality processes

Strong troubleshooting and root-cause analysis skills

Good communication skills to work with global/cross-site manufacturing and quality teams

Preferred Qualifications

Prior experience working within a global pharmaceutical manufacturing IT/MES deployment team

Exposure to change control and deviation management processes in a validated environment

Bachelor's degree in Engineering, Life Sciences, Computer Science, or related field

At Lilly, caring is not only what we do for patients. It is how we work. We believe the people who dedicate themselves to making medicines better deserve an environment that makes their lives better too, one where they are supported, respected, and given the space to do their best work. This is not just a policy. It is who we are.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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