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.
The Associate Director – Process Engineering PFS (Pre-Filled Syringes) reports directly to the Sr. Director of Engineering and is responsible for establishing and maintaining systems to ensure the reliable operation, maintenance, and qualified state of process equipment, through management of a team of about 20 resources (process engineers, maintenance manager, and maintenance technicians). Ensures that the process equipment is in control, compliant, and capable of meeting plant production needs, while also driving continuous improvement efforts. This position is responsible for serving as a subject matter expert in one or more disciplines and also providing technical and leadership guidance to the engineering team, while also understanding the business impact and drivers outside of their own business area.
Main responsibilities:
- Ensure appropriate technical support for all existing manufacturing processes
- Makes decisions guided by engineering standards and policies, procedures and business plan that impact the ability of the Process Engineers to meet performance objectives.
- Provide Functional Leadership to Process Team engineering representatives by coaching the following business processes: Change Management, Deviations/Investigations, Equipment and Process Improvements, Process Controls and Variability Reduction
- Support and peer review root cause analysis around equipment and operational events, support complex change controls, and investigations. Lead Complex investigations and have strong Root Cause analysis capability
- Ensure a continuous improvement mindset for process and operational improvements
- Apply statistical thinking and methods to understand process variability and capability and drive improvements.
- Support regulatory inspections
- Provide oversight to process equipment to ensure a clear understanding of equipment flow, process flow, and critical process requirements across all process steps on site.
- Establish control systems to monitor, trend, and verify equipment performance and downtime. Identify and Optimize unit operation cycle time, loading, yield performance, etc.
- Support or lead troubleshooting efforts to resolve equipment and operational problems, and ensure formal problem solving techniques are appropriately utilized.
- Lead the process safety agenda for the process equipment
- Understand and ensure compliance with engineering standards, and environment health & safety requirements.
- Develop, review and approve technical documentation such as SOPs, Batch Records, Investigations, etc.
- Present and attend various Governance teams to represent process engineering
Leadership
- This position involves direct management of Process Engineers and Maintenance Manager
- Provide leadership, training, development, and support of process engineering team members
- Engage and promote the use of internal and external networks to help deliver sound technical decisions.
- Promote the use of first principles with engineering staff, and drive engineering solutions for problems
- Monitor and ensure compliance with training requirements
Qualifications and key competencies:
- Master’s degree in engineering field
- English fluency
- +10 years of experience in engineering, maintenance, or technical support in pharmaceutical manufacturing companies
- Previous supervisory/ leadership experience is required
- Ability to instill teamwork within the department and demonstrate key interpersonal skills
- Ability to ensure appropriate technical depth and rigor with departmental technical deliverables
- Successful application of organizational models through recruiting and retention of employees
- Ability to make decisions independently and to network with others as appropriate
- Ability to provide innovative solutions to plant, divisional, and corporate issues and leverage ideas from other functional areas
- Ability to communicate verbally and in writing to various audiences, particularly one-on-one coaching and feedback with direct reports
- Ability to function in a team environment as a leader and as a member of management teams
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