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Associate Director-IDM CMO Process Engineering

5 months ago

Indianapolis, United States Eli Lilly and Company Full time

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.

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

This position will provide leadership for engineering resources to lead aspects scope development, design, delivery, and optimization of manual and automated device assembly processes and related equipment in support of IDM and Device network objectives for product commercialization, capacity expansion, and ongoing operations. The team is responsible to identify and ensure requirements for safety, quality; cost, reliability, and capacity are effectively met during project execution. This role serves as a key interface between local resources SME’s, project teams, OEM’s, CM’s, IDM leadership, and corporate initiatives.

Responsibilities:

Safety and Quality

Drive compliance with Lilly policies and procedures through assessments, audits, and/or feedback

Ensure staff is current with required safety and quality training

Drive integration of safe behaviors into project and technical teams through frequent observations and engagement

Ensure HSE focus during process and process design, testing, operation, and maintenance

Ensure appropriate application of engineering standards such as equipment guarding, alarm management, and ergonomic design

People

Build and support development and career plans for employees

Assist in identification and mitigation of technical capability gaps across IDM

Identify and use contract support staffing to fill capacity and capability gaps

Handle resource workload and allocation to project portfolio

Optimize organizational design/structure and recommendations for the business planning process around staffing levels

Proactively recognize and reward achievements and provide candid feedback for development

Train and certify project team resources and Lilly partners (CM’s, OEM’s and service providers) around Lilly expectations

Plan and optimize travel to balance business needs and work/life for employees

Business Leadership

Develop and communicate department metrics that provide foundation for continuous improvement

Develop and implement continuous improvement plans for local business processes

Identify business case and leverage value engineering opportunities

Collaborate closely with Lilly and/or contract manufacturing sites to integrate requirements into RFP and designs

Manage departmental expenses and/or capital to align with site target

Ensure appropriate allocation of employee time to capital, development, and product accounts

Engage and influence project and process teams to resolve raised issues and obstacles impacting team performance

Proactively communicate major initiative and team progress to stakeholders, team members, and peers

Provide technical guidance for OEM design, fabrication, and testing on capital programs

Drive conformance to schedule for technical activities through project engagement and obstacle elimination.

Develop and implement strategy for engineering studies.

Support development of testing strategies and troubleshoot equipment/automation issues.

Harmonize process mechanical and automation design for key equipment

Technical Excellence

Ensure appropriate level of technical difficulty in technical reports, process and equipment designs, and root cause investigations

Champion statistical thinking in experimental design and use of engineering first principles

Encourage and support proactive Design for Manufacturability, Safety, and Quality principles especially for new process designs

Benchmark, develop, share, and implement new technology in order to optimize value and reliability

Audit/assess team practices to ensure compliance with established technical guidelines or procedures

Identify and coordinate CQV contract resources to supplement Lilly project team

Lead the development and implementation of CQV strategies, processes, and metrics to optimize capital, speed, and compliance

Process Verification and Optimization

Basic Qualifications:

BS Engineering or related field

Additional Preferences:

Clear demonstration of leadership skills with supervisory experience and/or team leadership

Ability to work across boundaries with equipment suppliers, Lilly and contract manufacturing sites, contract engineering suppliers, and other Lilly organizations

Demonstrated knowledge of manufacturing equipment, controls, and validation practices

Direct experience within a manufacturing environment

Awareness of GMP and ISO requirements related to medical devices and device assembly operations

Previous experience with capital project delivery, commissioning, and qualification of automated systems

Process automation experience with discrete-manufacturing equipment

Operations, maintenance and equipment reliability experience

Additional Information:

Some travel required (10-25%)

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly is an EEO/Affirmative Action Employer and does 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.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

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