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Associate Director
1 month ago
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.
Position Brand Description: Are you ready to lead the charge in shaping the future of manufacturing at Eli Lilly? As an Associate Director of Engineering, you'll be at the forefront of this exciting journey. In this role within our Device and Packaging Network, you'll not only execute strategies and objectives but also inspire a culture of innovation and excellence. Collaborating with our top-notch team of leaders, you'll influence and implement our organizational agenda, business priorities, and quality objectives to drive success down to the floor level.
Key Objectives/Deliverables:
- Empowerment through Development: Mentor, coach, and recognize team members within your organization to foster growth, achievement and meet the needs of the business.
- Strategic Planning: Engage and support business plan objectives while tracking team performance and ensuring adequate resources are in place for successful implementation.
- Safety and Quality Culture: Lead by example in building and driving a culture of safety first and quality always within the organization while removing barriers to team performance. Review and approve GMP documentation including procedures, deviation investigations, technical reports, change controls, regulatory submissions, validation protocols and summary reports, PFDs, APRs, etc.
- Technical Excellence: Lead and provide technical input and effective process support for manufacturing issue resolution and investigations, champion continuous improvement initiatives, and adhere to engineering standards for groups including maintenance, process engineering, automation engineering, or local capital projects and management based on-site needs
- Process Optimization: Develop local processes and procedures to enhance efficiency and effectiveness, utilizing lean tools for success.
- Resource Management: Manage resources effectively, including workload optimization and staffing needs, to meet business objectives. Support Site Leadership to build a diverse and capable organization, supporting the areas of device assembly and packaging,
- Collaborative Leadership: Collaborate closely with cross-functional teams, external partners, central functional organizations, and suppliers to drive alignment and resolve escalated issues. Represent the team on plant flow teams, influencing technical agendas and driving operational results.
- Performance Metrics: Develop and communicate department metrics to drive continuous improvement and ensure alignment with business goals Develop team goals for safety, quality, and process effectiveness and efficiency.
- Innovation and Problem-Solving: Foster a culture of innovation and creativity, encouraging team members to identify and drive improvement opportunities. This position may deliver equipment, lines, and supporting systems through technology transfers or process validations.
- Regulatory Compliance: Ensure adherence to current regulatory requirements, including cGMP standards, OSHA regulations, and environmental sustainability goals. Support site inspection readiness and execution. This role has direct interaction with Regulatory Agencies during site inspections.
Minimum Requirements:
- Bachelor's Degree in Engineering, Science, or a related field.
- Regulatory Compliance: Ensure adherence to current regulatory requirements, including cGMP standards, OSHA regulations, and environmental sustainability goals. Support site inspection readiness and execution. This role has direct interaction with Regulatory Agencies during site inspections.
- 5+ years of manufacturing experience, pharmaceutical or regulated industry
- Innovation and Problem-Solving: Foster a culture of innovation and creativity, encouraging team members to identify and drive improvement opportunities. This position may deliver equipment, lines, and supporting systems through technology transfers or process validations.
- 3+ years demonstrated leadership skills with a history of successful team development.
- Performance Metrics: Develop and communicate department metrics to drive continuous improvement and ensure alignment with business goals Develop team goals for safety, quality, and process effectiveness and efficiency.
- Knowledge of cGMP requirements in medical device manufacturing.
- Understanding of basic requirements of regulatory agencies such as the FDA, DEKRA, and OSHA.
Additional Preferences:
- Excellent interpersonal, written, and oral communication skills that demonstrate an ability to effectively (clearly, succinctly) communicate with all levels of the organization for decisions, influencing, coaching and mentoring.
- Collaborative Leadership: Collaborate closely with cross-functional teams, external partners, central functional organizations, and suppliers to drive alignment and resolve escalated issues. Represent the team on plant flow teams, influencing technical agendas and driving operational results.
- Experience in device assembly and/or packaging.
- Previous equipment qualification and process validation experience
- Previous experience with deviation and change management systems including Trackwise
Additional Information:
Occasional travel may be required to support business needs.
PPE is required on the manufacturing floor.
This is an onsite position that requires onsite presence the majority of the time.
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.
#WeAreLilly
- Resource Management: Manage resources effectively, including workload optimization and staffing needs, to meet business objectives. Support Site Leadership to build a diverse and capable organization, supporting the areas of device assembly and packaging,
- Process Optimization: Develop local processes and procedures to enhance efficiency and effectiveness, utilizing lean tools for success.
- Technical Excellence: Lead and provide technical input and effective process support for manufacturing issue resolution and investigations, champion continuous improvement initiatives, and adhere to engineering standards for groups including maintenance, process engineering, automation engineering, or local capital projects and management based on-site needs
- Safety and Quality Culture: Lead by example in building and driving a culture of safety first and quality always within the organization while removing barriers to team performance. Review and approve GMP documentation including procedures, deviation investigations, technical reports, change controls, regulatory submissions, validation protocols and summary reports, PFDs, APRs, etc.
- Strategic Planning: Engage and support business plan objectives while tracking team performance and ensuring adequate resources are in place for successful implementation.
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