Sr. Principal Engineer - Automation Engineering - Biologics - Lilly Medicine Foundry
$67.5k - $173.8kLilly
At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us. 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. Organization and Position Overview Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. The first-ever facility of its kind, combining research and manufacturing in a single location, the Medicine Foundry will allow Lilly to further develop innovative solutions to optimize manufacturing processes and increase capacity for clinical trial medicines, while also reducing costs and environmental impact. The Sr. Principal Engineer - Automation Engineering will work as a member of the Automation Engineering Department at Eli Lilly, Foundry. The Sr. Principal engineer will provide automation support for one or more biologics operating areas across site (such as cell culture, purification, and buffer/media preparation) and/or for capital projects. Process Automation is core to delivering a right first time facility start up and continued support of ongoing manufacturing operations into the future. The Sr. Principal Engineer is also responsible for the productivity and mentorship of the employees with the purpose of ensuring that reliable and compliant-controlled applications and systems are used in the manufacturing at Foundry. Additionally, the Sr. Principal Engineer, as a key technical expert partners to influence and implement within the process control organization and across functional disciplines to support the process control technical agenda, business plan priorities, and compliance objectives. In the project delivery phase and startup phase of the project (startup expected 2025 to 2028), automation engineering roles will be fluid and dynamic as we endeavor to support the project delivery, build a new organization, develop and implement the necessary systems and business processes required to support GMP operations, and build the site culture. This will require significant collaboration, creativity and resilience as the site grows to a full scale GMP manufacturing through start up. Responsibilities Key Objectives/Deliverables:
- Technical Leadership
- Mentor process control team, including design, controls philosophy, implementation and commissioning
- Process control work implementation and coordination
- Review and monitor financial performance; commit to meeting targets
- Develop and implement the Automation Engineering Project Plan.
- Operational Excellence
- Technically lead and oversee the work of Site Area leads and System Integrator including Functional Requirements, Design Specifications, DCS Application Software, Test Specifications.
- Lead/Participate in design reviews and DeltaV application software reviews, attend equipment and software FATs
- Lead a team of automation engineers supporting commissioning
- Provide periodic status updates to Project Management
- Devise functional requirements and process control strategies for control systems in collaboration with Process Engineering
- DCS and SCADA software design, coding/configuration and testing (sequence logic, graphics, batch software etc.) for biologics unit operations
- Design, configure and test batch automation for biologics unit operations, including bioreactors and cell culture, harvest, chromatography, ultrafiltration/diafiltration (UF/DF), viral inactivation and filtration, buffer and media preparation, and CIP/SIP
- Lead integration of vendor-supplied skids, single-use systems and PLC/HMI-based equipment packages into the site DCS, MES and historian architecture
- Perform automation engineering activities including design, tuning and troubleshooting of control loops
- Implement and support electronic systems (such as plant historians, applications and software integration) used to capture process automation related production data
- Maintain the validated state of the site control systems in line with Lilly quality standards including the development and execution of validation strategies and associated documentation
- Automation support for capital projects including new product introductions
- Promoting the use of automation to improve productivity, operational efficiency and compliance
- Developing a ‘network’ of corporate contacts and leveraging corporate expertise when needed
- Organizational Capability
- In coordination with automation and compliance consultants, set and reinforce standards for appropriate rigor in automation work products.
- Demonstrated initiative, good planning and organizational skills, ability to prioritize tasks, commitment to task completion and timelines.
- Possess a keen technical curiosity and has demonstrated strong problem-solving skills and a desire for continuous improvement
- Demonstrated ability to influence peers and business partners
- Good written and verbal communication skills for both technical and non-technical audiences
- Support the flow leadership in running the plant, including participation in management sub-teams.
- Knowledge of GMP, regulatory requirements, computer system validation
- Minimum B.S. in Engineering or related discipline and 8+ years working experience in Automation Engineering, preferably in Biologics manufacturing (e.g., cell culture, purification, or drug substance/drug product operations).
- Experience in design, development, commissioning and qualification of highly automated greenfield or brownfield manufacturing sites utilizing SCADA, DCS, PLC and MES systems (DeltaV, Rockwell, Syncade, etc).
- Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.
- Experience automating biologics manufacturing processes (mammalian cell culture, harvest, chromatography, UF/DF, viral clearance, buffer/media preparation) highly preferred. Experience with single-use technologies, monoclonal antibodies, or ADCs (antibody drug conjugates) preferred
- Experience with CIP/SIP automation, process analytical technology (PAT) and integration of automated skids and OEM equipment into a plant-wide control architecture preferred
- Experience in facilitating and driving decision-making at an organizational level.
- Ability to instill teamwork within the department and demonstrate key interpersonal skills.
- Proficient in DeltaV Distributed Control System, Rockwell Allen-Bradley PLC, and batch process automation.
- Experience with ISA-88 Batch-control standard models, terminology, recipes and procedural elements.
- Prior work with 21 CFR Part 11 and cGMP regulatory requirements, including computer system validation.
- Proven ability to influence peers and business partners, including influencing without authority, and to facilitate decision-making at an organizational level.
- Initial location at Parkwood West, Indianapolis.
- Permanent location at the new Lilly Medicines Foundry in Lebanon, Indiana.
- Travel Percentage: Some travel required to support equipment/software Factory Acceptance Tests (FATs), typically at vendor or system integrator sites.
- Act as an escalation resource for complex operational and process inquiries, delivering advanced support and issue resolution as business needs arise. Need-based off-hour support may be needed.
$67.5k - $173.8k
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