Engineer \u2013 Digital CMC PLM

Job Description 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 u202Fu00A0 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:u00A0Engineer u2013 Digital CMC PLMu00A0 u00A0 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.u00A0 Key Responsibilities:u202Fu00A0 What you will be doing:u00A0 u00B7u00A0u00A0u00A0u00A0u00A0u00A0 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.u00A0 u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Assistu00A0in the design and execution of data transfer protocols, ensuring adherence to CMC standards and regulatory requirements under the guidance of senior engineers.u00A0 u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Digital CMC & PLM Systems:u00A0Support configuration, maintenance, and governance of digital PLM systems (e.g.,u00A0QbDVision), including management of data structures, metadata standards, versionu00A0controland workflow configurations.u00A0 u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Analyzeu00A0and resolve routine data discrepancies during production data transfers, escalating complex issues to senior team members.u00A0 u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Execute data validation and verification tasks tou00A0maintainu00A0data integrity and traceability throughout the product lifecycle.u00A0 u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Participate in system build activities such as data migration, controlled document updates, and integration support with other manufacturing digital platforms (LIMS, MES, ERP).u00A0 u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Ensure compliance withu00A0GxP,u00A0Good Documentation Practices (GDP)u00A0andu00A0structured data management/migrationu00A0processes.u00A0 u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Contribute to cross-team alignment tou00A0identifyu00A0data gaps and implement corrective actions under supervision.u00A0 u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Support knowledge transfer and mentoring initiatives for junior engineers or team members.u00A0 u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Assistu00A0in process optimization, system enhancements, and continuous improvement initiatives to improve PLM efficiency and data governance.u00A0 u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Accuratelyu00A0executeu00A0data migration, validation, and integration tasksu00A0with minimal errors.u00A0 How you will succeed:u202Fu00A0 Effective Collaboration & Communicationu00A0 ou00A0u00A0u00A0u00A0u00A0u00A0u00A0 Work closely with TSMS, QA, and PD teams tou00A0understand business and regulatory requirements.u00A0 ou00A0u00A0u00A0u00A0u00A0u00A0u00A0 Communicate issues clearly and escalate complex problems appropriately to senior engineers.u00A0 ou00A0u00A0u00A0u00A0u00A0u00A0u00A0 Activelyu00A0participateu00A0in cross-functional meetings to ensure alignment on data and process standards.u00A0 Problem-Solving & Continuous Improvementu00A0 ou00A0u00A0u00A0u00A0u00A0u00A0u00A0 Identifyu00A0and resolveu00A0routine data discrepanciesu00A0efficiently.u00A0 ou00A0u00A0u00A0u00A0u00A0u00A0u00A0 Contribute tou00A0process optimization and system enhancement initiatives.u00A0 ou00A0u00A0u00A0u00A0u00A0u00A0u00A0 Demonstrate initiative inu00A0learning new tools, technologies, or PLM best practices,u00A0supporting broader team success.u00A0 What you should bring:u202Fu00A0 u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Detail-oriented with a strong quality assurance mindset.u00A0u00A0 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 Basic Qualifications and Experience Requirement:u202Fu00A0 u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Bacheloru2019s degreeu00A0in Pharmacy, Pharmaceutical Sciences, Biotechnology, Chemical Engineering, Computer Science, or related field.u00A0 u00B7u00A0u00A0u00A0u00A0u00A0u00A0 5+ years of experience inu00A0digital CMC, PLM, or regulated manufacturing IT systems.u00A0 u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Hands-on experience withu00A0PLM systemsu00A0such asu00A0QbDVision, Veeva Vault QMS, or Windchill.u00A0 u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Familiarity withu00A0GxPu00A0regulations, GDP, and data integrity requirements.u00A0 u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Experience supportingu00A0system integrationsu00A0with LIMS, MES, or ERP platforms.u00A0 Additional Skills/Preferences:u202Fu00A0 u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Exposure tou00A0data migration, workflow automation, or reporting toolsu00A0(Power BI, Tableau).u00A0 u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Basic scripting or automation skills to support PLM system processes.u00A0 u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Strong problem-solving, analytical, and documentation skills.u00A0 u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Ability to work effectively inu00A0cross-functional teamsu00A0and support continuous improvement initiatives.u00A0 u00A0 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. #WeAreLilly