Engineer Digital CMC PLM

5 - 9 years

0 Lacs

Posted:1 week ago| Platform: Shine logo

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On-site

Job Type

Full Time

Job Description

Role Overview: At Lilly, we are looking for a Digital CMC Configuration Engineer to join the Product Lifecycle Management (PLM) program team. As a key member, you will be responsible for configuring manufacturing data within the digital PLM platform, supporting deployments, and ensuring continuous improvement. Key Responsibilities: - Collaborate with cross-functional teams to implement digital product control strategies in the PLM system. - Assist in designing and executing data transfer protocols while adhering to CMC standards and regulatory requirements. - Support configuration, maintenance, and governance of digital PLM systems. - Analyze and resolve routine data discrepancies during production data transfers. - Execute data validation tasks to maintain data integrity throughout the product lifecycle. - Participate in system build activities such as data migration and controlled document updates. - Ensure compliance with GxP, GDP, and structured data management processes. - Contribute to process optimization and continuous improvement initiatives. - Assist in knowledge transfer and mentoring for junior engineers. - Accurately execute data migration and integration tasks with minimal errors. Qualification Required: - Bachelor's degree in Pharmacy, Pharmaceutical Sciences, Biotechnology, Chemical Engineering, Computer Science, or a related field. - 5+ 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. - 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.,

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