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.
Purpose:
The Clinical Services, Supplies & Capabilities (CSSC) organization is responsible for strategically planning and supplying materials, trial support services and innovative capabilities to support the execution of clinical trials globally for all business units across all phases of development. This group is within the Clinical Capabilities organization and partners across functions within the CDDA and PRD to influence trial design and provide solutions to operationalize these trials and enable asset strategies across the portfolio.
The Automation Engineer - Clinical Supplies and Services, Engineering is a senior level engineering role that requires technical depth in a broad range of automation, control, and data historian subject areas. This role provides broad design expertise and project engineering through an extensive network across the automation field. This role influences throughout the organization. Successfully directs programs involving multiple groups, projects, or locations. The person in this role mentors other engineers in automation engineering capability and career development.
This role will be expected to have a strong first principles foundation, and routinely apply engineering judgment and first principles to the engineering problems encountered during projects. Expertise with Rockwell Automation is preferred. Experience with data historian management is highly preferred.
Primary Responsibilities
Ensure understanding of global regulations and the external environment which impacts Clinical Services and Supplies and enable a strategic engineering plan to manage and influence this space.
Collaborate with appropriate functional areas to ensure they have the capabilities that enable Clinical Services and Supplies and a qualification process aligned with established GXP requirements.
Network and influence internally and externally to determine best practices for managing services and capabilities in the space.
Responsible for the application of corporate engineering standards.
Provide technical expertise in clinical trial enablement activities and expertise to influence, drive understanding and partner with leaders within Clinical Capabilities, CDDA, Quality, Facility Management, and business units/research.
Continue to drive improvements throughout the department and ensure procedures & processes are robust and up to date.
Provide strong business and financial acuity while minimizing risk, delays, and potential interruption of clinical trials.
Proactively manage issues, propose mitigation/response plans to resolve issues and effectively implement action plans that translate across the portfolio.
Create an environment that fosters and encourages cooperation, mutual respect, diversity, inclusion, thoughtful and informed decision making.
Key Deliverables
Ownership of the local data historian instance
Oversight of the automation engineering continuous improvement agenda for the Mobile Research Unit
Ongoing maintenance and repair of Gen 1 and 2 MRU.
Ongoing MRU configuration & capability changes to match CT needs, current and future.
Development of engineering key findings, design, and construction of Gen 3 MRU’s.
Oversight of GMP maintenance of monitoring equipment.
Web-based MRU control in collaboration with appropriate functions.
Spare parts management.
Facilities and Safety
Develop and implement appropriate safety programs.
Clinical Support Services and Future Technologies
MRU Automation, e.g. temperature control
Data management, analytics, and reporting
Development of technologies to meet future portfolio demands
Kitting & Packaging innovation
Basic Qualification Requirements:
Bachelor’s degree in an Engineering preferably in Chemical, Electrical, Computer, or Mechanical Engineering
5 or more years of proven experience in Process Control Engineering.
Additional Preferences:
Codesys PLC experience is highly preferred
Understanding of site operations and ability to establish strong rapport with engineering management at the site as well as central engineering partners
Demonstrated strong and effective written and verbal communication skills in multi-cultural and multi-functional settings.
Apply a continuous learning approach to drive improvements in effectiveness and efficiency of deployments based on learning from the field.
Ability to build productive relationships and effectively connect with CDDA, PRD, and Engineering leadership.
Ability to work in an independent, flexible environment.
Solid understanding of GXP regulations and requirements.
Previous Quality experience.
Previous Automotive/DOT experience.
Project management.
Additional Information
Work outside of core hours may be required to support the portfolio across the globe.
May require travel domestically and international (less than 5%).
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