Associate Director-IDM CMO Process Engineering

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.

Do not pass up this chance, apply quickly if your experience and skills match what is in the following description.

This position will provide leadership for engineering resources to lead aspects of 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

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

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%)

J-18808-Ljbffr