Engineer – Digital CMC PLM

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.

About the Technology Organization:   

Technology at Lilly builds and maintains capabilities using cutting edge technologies like most prominent tech companies. What differentiates Technology at Lilly is that we create new possibilities through tech to advance our purpose – creating medicines that make life better for people around the world, like data driven drug discovery and connected clinical trials. We hire the best technology professionals from a variety of backgrounds, so they can bring an assortment of knowledge, skills, and diverse thinking to deliver innovative solutions in every area of the enterprise.   

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.  

Job Title: Engineer – Digital CMC PLM 

The Digital CMC (Chemistry, Manufacturing, and Controls) Configuration Engineer is a key member of the Product Lifecycle Management (PLM) program team, responsible for hands-on configuration, data migration, and quality assurance of manufacturing  data within the digital PLM platform. This role supports accelerated delivery and sustainable internal PLM capability at Lilly, working closely with cross-functional teams to ensure successful deployments and continuous improvement. 

Key Responsibilities:  

What you will be doing: 

·       Collaborate with cross-functional teams, including Technical Services/Manufacturing Science (TSMS), Quality Assurance (QA), and Process Development (PD), to support implementation of digital product control strategies in the PLM system. 

·       Assist in the design and execution of data transfer protocols, ensuring adherence to CMC standards and regulatory requirements under the guidance of senior engineers. 

·       Digital CMC & PLM Systems: Support configuration, maintenance, and governance of digital PLM systems (e.g., QbDVision), including management of data structures, metadata standards, version controland workflow configurations. 

·       Analyze and resolve routine data discrepancies during production data transfers, escalating complex issues to senior team members. 

·       Execute data validation and verification tasks to maintain data integrity and traceability throughout the product lifecycle. 

·       Participate in system build activities such as data migration, controlled document updates, and integration support with other manufacturing digital platforms (LIMS, MES, ERP). 

·       Ensure compliance with GxP, Good Documentation Practices (GDP) and structured data management/migration processes. 

·       Contribute to cross-team alignment to identify data gaps and implement corrective actions under supervision. 

·       Support knowledge transfer and mentoring initiatives for junior engineers or team members. 

·       Assist in process optimization, system enhancements, and continuous improvement initiatives to improve PLM efficiency and data governance. 

·       Accurately execute data migration, validation, and integration tasks with minimal errors. 

How you will succeed:  

Effective Collaboration & Communication 

o Work closely with TSMS, QA, and PD teams to understand business and regulatory requirements. 

o Communicate issues clearly and escalate complex problems appropriately to senior engineers. 

o Actively participate in cross-functional meetings to ensure alignment on data and process standards. 

Problem-Solving & Continuous Improvement 

o Identify and resolve routine data discrepancies efficiently. 

o Contribute to process optimization and system enhancement initiatives. 

o Demonstrate initiative in learning new tools, technologies, or PLM best practices, supporting broader team success. 

What you should bring:  

·       Detail-oriented with a strong quality assurance mindset.  

·       Solid understanding of PLM CMC master data (products, processes, formulations, regulatory elements) and product lifecycle (development through commercial GMP manufacturing).  

·       Experienced in resolving data gaps and inconsistencies, and performing validation and verification checks.  

·       Hands-on experience with Digital CMC systems (e.g., QbDVision) and PLM configuration/data entry is preferable. 

·       Knowledge of controlled vocabularies, metadata standards, and version control.  

·       Strong communication skills and active contributor to training and knowledge transfer activities.  

Basic Qualifications and Experience Requirement:  

·       Bachelor's degree in Pharmacy, Pharmaceutical Sciences, Biotechnology, Chemical Engineering, Computer Science, or related field. 

· years of experience in digital CMC, PLM, or regulated manufacturing IT systems. 

·       Hands-on experience with PLM systems such as QbDVision, Veeva Vault QMS, or Windchill. 

·       Familiarity with GxP regulations, GDP, and data integrity requirements. 

·       Experience supporting system integrations with LIMS, MES, or ERP platforms. 

Additional Skills/Preferences:  

·       Exposure to data migration, workflow automation, or reporting tools (Power BI, Tableau). 

·       Basic scripting or automation skills to support PLM system processes. 

·       Strong problem-solving, analytical, and documentation skills. 

·       Ability to work effectively in cross-functional teams and support continuous improvement initiatives. 

Additional Information: N/A  

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 ) 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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