Project Engineer - API Manufacturing at Eli Lilly and Company

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 unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 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.

Lilly is currently constructing an advanced manufacturing facility for production of API molecules located in Lebanon, IN.  This facility is Lilly’s largest investment in manufacturing capacity and is intended to provide APIs for current and future products.  This is a unique opportunity to be a part of the leadership team for the startup of a greenfield manufacturing site, and the successful candidate will help to build the organization, the facility and the culture to enable a successful startup into GMP manufacturing operations. 

This position will begin almost immediately with an assignment as a project engineer at a Lilly facility in Puerto Rico for approximately a year. Upon completion of the year, the project engineer will re-locate to Lebanon, IN to support start up activities.

The mission of the Project Engineer – API Manufacturing is to deliver capital projects from concept through close-out that are typically less than $1,000,000 in value but may range upwards to $5,000,000. The project engineer may also be assigned to represent API on major capital projects managed by Lilly's Corporate Engineering function. This role is also key in establishing disciplined project implementation best practices and benchmarking, utilize sound engineering principles to safely create, qualify, maintain and continuously improve the processes, facilities and equipment needed to deliver our product pipeline across batch and continuous API production and development. These results are accomplished by utilizing various elements of the engineering discipline including, but not limited to: first principles, lean manufacturing, project management strategies.

Responsibilities:

• Drive completion of assigned projects by leading multi-disciplinary, multi-location teams to develop scope, agree to design, and efficiently execute implementation of project goals.
• Provide financial justification/benefit, secure agreement to obtain required internal/external resources and identify/develop other possible alternatives or solutions to the proposed project and resolves issues through data driven decision making.
• Use technical experience and understanding to generate sound technical solutions.
• Accountability for financial performance of assigned projects including preparation of CIRs, development of schedules and cost estimates, and maintenance and control of project scope, schedule, and budget.
• Ensuring that Lilly requirements for design qualification, PSM, change management, document management, commissioning, qualification, validation and construction control are satisfied.
• Providing an interface with and coordination for both Lilly and third party partners including Automation, Lilly Life Safety, A&E firms, Central Indiana Alliance, and vendors.
• Financial tracking and management of assigned projects within the SAP system and in compliance with FRAP.
• Providing SAP based services including submittal of requisitions, contract development, and invoice payment for capital or expense projects, as required.
• Closure of completed projects to ensure appropriate capitalization.
• Continuously improve project planning and execution practices.
• Engage in the annual resource assessment and capital business planning processes.
• Formally communicate project information for internal and external project team members and stakeholders.

Basic Qualifications:

• BS in Chemical, Mechanical or similar Engineering discipline
• 2+ years’ experience in a pharmaceutical, chemical, or similar environment.
• Experience in project management fundamentals and methodologies.
• Candidate must be mobile to Puerto Rico.

Additional Skills/Preferences:

• Must have a solid understanding of pharmaceutical regulations, commissioning and qualification, expense vs. capital, and project implementation strategies.
• Must have good communication skills (both written and verbal).
• Be able to lead cross-functional, multi-discipline, multi-location teams.
• Must be well organized and able to successfully lead a project team to obtain the best results for the business.
• Solid understanding of the cGMPs and all available technical resources (Corporate Policies and Procedures, Engineering Technical Guidelines, Master Specifications, drawing management, etc).
• Knowledgeable regarding Lilly GFD project delivery process.
• Able to function as owner/user representative during major capital projects

Additional Information:

• Ability to travel up to 25% for vendor management.
• Normal working hours are day shift, Monday through Friday. Occasional off-hour coverage may be required due to planned shutdowns, emergency support, and project requirements.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

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