Senior 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: Senior Technical 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: 

·       Lead collaboration with cross-functional SMEs from Technical Services/Manufacturing Science (TSMS), Quality Assurance (QA), and Process Development (PD) to define and implement digital product control strategies within the PLM ecosystem. 

·       Oversee and approve data transfer protocol design and execution, ensuring alignment with global CMC standards and regulatory expectations. 

·       Drive configuration and governance of digital PLM systems (e.g., QbDVision), managing data structures, metadata standards, controlled vocabularies, and version control frameworks to ensure accuracy and compliance. 

·       Resolve complex data and process discrepancies during production data transfers through deep technical analysis and cross-team coordination. 

·       Establish and enforce data validation and verification frameworks to uphold data integrity and traceability throughout the product lifecycle. 

·       Provide expert oversight for critical system build tasks, including data migration, integration, and controlled document updates. 

·       Architect and optimize integration between manufacturing digital platforms such as LIMS, MES, and ERP systems to enable seamless data flow and interoperability. 

·       Champion compliance and documentation excellence, ensuring adherence to Good Documentation Practices (GDP) and structured data migration processes. 

·       Lead cross-workstream alignment to proactively identify, analyze, and remediate data gaps and inconsistencies across systems and processes. 

·       Mentor and guide teams through knowledge transfer, shadowing, and transition activities to strengthen internal ownership and operational maturity. 

·       Drive continuous improvement in system design, process efficiency, and data governance; contribute to internal training and capability-building initiatives. 

How you will succeed:  

·       Act as a technical anchor — combining deep domain knowledge of CMC processes with strong digital system expertise to translate scientific and manufacturing needs into robust, compliant PLM configurations. 

·       Demonstrate systems thinking — understand how data flows across PLM, LIMS, MES, and ERP ecosystems to design integrations that enhance visibility, traceability, and product lifecycle continuity. 

·       Drive data integrity excellence — proactively identify risks, close data gaps, and uphold structured, compliant information management practices across global functions. 

·       Lead through collaboration — build trusted partnerships with TSMS, QA, PD, and IT stakeholders, ensuring alignment between business requirements, technical solutions, and regulatory standards. 

·       Deliver with precision and accountability — own end-to-end configuration, data migration, and validation activities, ensuring on-time delivery and sustained system reliability. 

·       Champion continuous improvement — challenge the status quo, streamline digital workflows, and share best practices that advance digital maturity and operational efficiency across teams. 

·       Enable team capability growth — mentor peers, facilitate knowledge transfer, and foster a culture of technical curiosity and disciplined execution. 

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.  

·       Strong knowledge of data management concepts: 

o   Data migration, version control, metadata standards, controlled vocabularies. 

o   Data validation, verification, and integrity frameworks. 

Basic Qualifications and Experience Requirement:  

· Bachelor's or Master's degree in Computer Science, Information Technology, Biotechnology, Chemistry, or a related discipline. 

· years of experience in TSMS with 5+ years in PLM. 

· Hands-on experience with PLM systems (e.g., QbDVision, Veeva Vault QMS, Windchill, or similar) 

· Familiarity with digital CMC processes, product lifecycle data, and regulatory requirements (GxP, FDA, ICH guidelines). 

Additional Skills/Preferences:  

·       PLM System Expertise: Advanced knowledge of QbDVision or similar digital CMC/PLM platforms (Veeva Vault QMS, Windchill, etc.). 

·       Scripting / Automation: Ability to write simple scripts or use workflow automation tools to improve data transfer, reporting, or integration processes. 

·       Data Analytics & Reporting: Familiarity with data visualization tools (Tableau, Power BI) to analyze trends, data quality issues, or KPI reporting. 

·       Cloud & SaaS Platforms: Understanding of cloud-based PLM or LIMS deployments. 

·       GxP Compliance: Understanding of GMP, GDP, and electronic records regulations (21 CFR Part 11, Annex 11). 

·       Quality Systems Integration: Familiarity with LIMS, MES, ERP integration in regulated environments. 

·       Product Lifecycle Knowledge: Understanding of CMC processes, technical transfer, and regulatory submissions. 

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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