Senior Engineer \u2013 Digital CMC PLM

About the Technology Organization:u202Fu202Fu00A0

Technology at Lilly builds andu00A0maintainsu00A0capabilities usingu00A0cutting edgeu00A0technologies like most prominent tech companies. What differentiates Technology at Lilly is that we create new possibilities through tech to advance our purpose u2013 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.u202Fu202Fu00A0

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About the Business Function:u202Fu00A0

From molecule to market, Global Manufacturing playsu00A0an important roleu00A0in every step along a productu2019s 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.u202Fu202Fu00A0

Global Manufacturingu00A0comprisesu00A0a core group of functions that contribute to the production and supply of high-quality products: Engineering Manufacturing Information & Control Systemsu00A0Quality & Labs,u00A0Technology Services/Manufacturing Science Global Health, Safety and Environment and Global Supply Chain.u202Fu00A0

Job Title:u00A0Senior Technicalu00A0Engineer u2013 Digital CMC PLMu00A0

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The Digital CMCu00A0(Chemistry, Manufacturing, and Controls)u00A0Configuration Engineer is a key member of the Product Lifecycle Management (PLM) program team, responsible for hands-on configuration, data migration, and quality assurance ofu00A0manufacturingu00A0 datau00A0within 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.u00A0u00A0

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Key Responsibilities:u202Fu00A0

What you will be doing:u00A0

u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Lead collaborationu00A0with 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.u00A0

u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Oversee and approveu00A0data transfer protocol design and execution, ensuring alignment with global CMC standards and regulatory expectations.u00A0

u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Drive configuration and governanceu00A0of digital PLM systems (e.g.,u00A0QbDVision), managing data structures, metadata standards, controlled vocabularies, and version control frameworks to ensure accuracy and compliance.u00A0

u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Resolve complex data and process discrepanciesu00A0during production data transfers through deep technical analysis and cross-team coordination.u00A0

u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Establish and enforce data validation and verification frameworksu00A0to uphold data integrity and traceability throughout the product lifecycle.u00A0

u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Provide expert oversightu00A0for critical system build tasks, including data migration, integration, and controlled document updates.u00A0

u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Architect andu00A0optimizeu00A0integrationu00A0between manufacturing digital platforms such as LIMS, MES, and ERP systems to enable seamless data flow and interoperability.u00A0

u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Champion compliance and documentation excellence, ensuring adherence to Good Documentation Practices (GDP) and structured data migration processes.u00A0

u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Lead cross-workstream alignmentu00A0to proactivelyu00A0identify,u00A0analyze, and remediate data gaps and inconsistencies across systems and processes.u00A0

u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Mentor and guide teamsu00A0through knowledge transfer, shadowing, and transition activities to strengthen internal ownership and operational maturity.u00A0

u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Drive continuous improvementu00A0in system design, process efficiency, and data governance contribute to internal training and capability-building initiatives.u00A0

How you will succeed:u202Fu00A0

u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Act as a technical anchoru00A0u2014 combining deep domain knowledge of CMC processes with strong digital systemu00A0expertiseu00A0to translate scientific and manufacturing needs into robust, compliant PLM configurations.u00A0

u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Demonstrate systems thinkingu00A0u2014 understand how data flows across PLM, LIMS, MES, and ERP ecosystems to design integrations that enhance visibility, traceability, and product lifecycle continuity.u00A0

u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Drive data integrity excellenceu00A0u2014 proactivelyu00A0identifyu00A0risks, close data gaps, and uphold structured, compliant information management practices across global functions.u00A0

u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Lead through collaborationu00A0u2014 build trusted partnerships with TSMS, QA, PD, and IT stakeholders, ensuring alignment between business requirements, technical solutions, and regulatory standards.u00A0

u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Deliver with precision and accountabilityu00A0u2014 own end-to-end configuration, data migration, and validation activities, ensuring on-time delivery and sustained system reliability.u00A0

u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Champion continuous improvementu00A0u2014 challenge the status quo, streamline digital workflows, and share best practices that advance digital maturity and operational efficiency across teams.u00A0

u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Enable team capability growthu00A0u2014 mentor peers,u00A0facilitateu00A0knowledge transfer, and foster a culture of technical curiosity and disciplined execution.u00A0

What you should bring:u202Fu00A0

u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Detail-oriented with a strong quality assurance mindset.u00A0

u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Solid understanding of PLM CMC master data (products, processes, formulations, regulatory elements) and product lifecycle (development through commercial GMP manufacturing).u00A0u00A0

u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Experienced in resolving data gaps andu00A0inconsistencies, andu00A0performing validation and verification checks.u00A0u00A0

u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Hands-on experience with Digital CMC systems (e.g.,u00A0QbDVision) and PLM configuration/data entry is preferable.u00A0

u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Knowledge of controlled vocabularies, metadata standards, and version control.u00A0u00A0

u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Strong communicationu00A0skills and active contributor to training and knowledge transfer activities.u00A0u00A0

u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Strong knowledge ofu00A0data management concepts:u00A0

ou00A0u00A0 Data migration, version control, metadata standards, controlled vocabularies.u00A0

ou00A0u00A0 Data validation, verification, and integrity frameworks.u00A0

Basic Qualifications and Experience Requirement:u202Fu00A0

u00B7u00A0u00A0u00A0u00A0u00A0u00A0u00A0u00A0u00A0u00A0u00A0u00A0u00A0u00A0u00A0 Bacheloru2019s oru00A0Masteru2019s degreeu00A0in Computer Science, Information Technology, Biotechnology, Chemistry, or a related discipline.u00A0

u00B7u00A0u00A0u00A0u00A0u00A0u00A0u00A0u00A0u00A0u00A0u00A0u00A0u00A0u00A0u00A0 12+u00A0years of experienceu00A0inu00A0TSMS with 5+ years in PLM.u00A0

u00B7u00A0u00A0u00A0u00A0u00A0u00A0u00A0u00A0u00A0u00A0u00A0u00A0u00A0u00A0u00A0 Hands-on experience withu00A0PLM systemsu00A0(e.g.,u00A0QbDVision, Veeva Vault QMS, Windchill, or similar)u00A0

u00B7u00A0u00A0u00A0u00A0u00A0u00A0u00A0u00A0u00A0u00A0u00A0u00A0u00A0u00A0u00A0 Familiarity withu00A0digital CMC processes, product lifecycle data, and regulatory requirements (GxP, FDA, ICH guidelines).u00A0

Additional Skills/Preferences:u202Fu00A0

u00B7u00A0u00A0u00A0u00A0u00A0u00A0 PLM System Expertise:u00A0Advanced knowledge ofu00A0QbDVisionu00A0or similar digital CMC/PLM platforms (Veeva Vault QMS, Windchill, etc.).u00A0

u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Scripting / Automation:u00A0Ability to write simple scripts or use workflow automation tools to improve data transfer, reporting, or integration processes.u00A0

u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Data Analytics & Reporting:u00A0Familiarity with data visualization tools (Tableau, Power BI) tou00A0analyzeu00A0trends, data quality issues, or KPI reporting.u00A0

u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Cloud & SaaS Platforms:u00A0Understanding of cloud-based PLM or LIMS deployments.u00A0

u00B7u00A0u00A0u00A0u00A0u00A0u00A0 GxPu00A0Compliance:u00A0Understanding of GMP, GDP, and electronic records regulations (21 CFR Part 11, Annex 11).u00A0

u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Quality Systems Integration:u00A0Familiarity with LIMS, MES, ERP integration in regulated environments.u00A0

u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Product Lifecycle Knowledge:u00A0Understanding of CMC processes, technical transfer, and regulatory submissions.u00A0

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Additional Information:u00A0N/Au202Fu00A0

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.

Lillyu00A0does 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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