Project Engineer - API Manufacturing

Eli Lilly and Company; Indiana (PA); On-site; USD 70,000 - 110,000; Full time

Job summary

An established industry player is looking for a Project Engineer to lead the startup of a new API manufacturing facility. This role offers a unique opportunity to drive capital projects from concept to execution, ensuring compliance with pharmaceutical regulations while working with cross-functional teams. You'll be instrumental in establishing best practices and improving project planning and execution. If you're passionate about making a difference in healthcare and possess strong project management skills, this is the perfect chance to contribute to life-changing medicines and be part of a dedicated team focused on innovation and excellence.

Benefits

Health Care Plans

Paid Time Off

Retirement Plans

Flexible Work Hours

Qualifications

• Bachelor's degree in Chemical or Mechanical Engineering is required.
• 2+ years of experience in a pharmaceutical or chemical environment.

Responsibilities

• Lead multi-disciplinary teams to complete capital projects effectively.
• Ensure compliance with design qualification and project management standards.

Skills

Project Management

Pharmaceutical Regulations

Cross-Functional Team Leadership

Data Driven Decision Making

SAP System Management

cGMP Knowledge

Education

BS in Chemical Engineering

BS in Mechanical Engineering

Tools

SAP

Job description

Project Engineer - API Manufacturing

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 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, utilizing 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.

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 resolve 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 for further assistance.

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.

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