Project Engineer - Design Lead

Initial Therapeutics, Inc.; Indianapolis (IN); On-site; USD 80,000 - 120,000; Full time

Job summary

An established industry player is seeking a Design Verification Lead to enhance its global facilities delivery efforts. This pivotal role involves overseeing the design delivery for capital projects, ensuring adherence to engineering standards and regulatory requirements. You will collaborate with design teams and project managers to facilitate efficient project execution, while also addressing design-related challenges. The ideal candidate will possess a strong background in pharmaceutical engineering and project management, with a commitment to driving innovation and efficiency. Join a team dedicated to making a meaningful impact on healthcare and improving lives around the world.

Qualifications

• 5+ years of experience in manufacturing or engineering in pharmaceutical networks.
• Strong understanding of A/E design activities and capital project delivery.

Responsibilities

• Lead design delivery for capital projects and ensure compliance with standards.
• Coordinate design phases and expedite decisions for project efficiency.
• Review design-related invoices and manage discrepancies in the verification phase.

Skills

Project Management

Conflict Resolution

Design Verification

Pharmaceutical Engineering

Capital Project Delivery

Education

BS in Engineering

Job description

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 serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

The Global Facilities Delivery (GFD) Organization, part of Corporate Engineering and Continuous Improvement, delivers new and renovated capital assets around the world. Our mission is accomplished through a highly leveraged organization of design, construction and qualification contractors. Many of the assets delivered focus on medical innovation and delivering innovative solutions to patients. Some of the assets delivered will support an expansion in supply of existing medicines or making the supply chain more robust. The Design Verification Lead (DVL) will serve in the following capacity:

Responsibilities:

1. Lead in the identification of the applicable Engineering Design Standards, Engineering Functional Standards, Engineering Specifications and Regulatory requirements and guidance (both internal and external).
2. Be responsible for the overall design delivery for capital project(s).
3. Coordinate all design for the Project Manager during all design phases of the project and be responsible in delivering the conceptual design review and basic design review.
4. Direct the development of the design requirements.
5. Assist in development and maintenance of the design schedule to meet the project needs.
6. Participate in the selection of the A/E firms.
7. Coordinate with A/E firms to develop earned value progress systems to measure progress by discipline (monitor work versus invoice amounts).
8. Expedite design decisions and coordinate information flow between the design team and system owners.
9. Be responsible for ensuring the design meets approved intent through interactions between the design firm, design specialists, engineering tech center disciplines, and end user/customer.
10. Be responsible for design activities and governance, resolving design-related problems.
11. Examine areas of inefficiency and develop strategies for improvement to direct the design team to meet or improve on the design hours plan.
12. Assist in the development of standard operating procedures, project delivery work instructions, and/or best practices related to design/verification and ensure they remain current with industry best practices.
13. Review and approve along with the respective Project Manager the key design project personnel (both internal and external resources).
14. Work with Engineering Tech Center resources and other key project team technical/constructability resources to address and resolve design issues.
15. Ensure replication is achieved during design when applicable.
16. Support the Project Manager for value engineering exercises efforts to maximize project opportunities.
17. Review design-related invoices prior to approval and participate in KPI reviews/assessments.
18. Participate in the selection of the verification professional services.
19. Accountable for the development of the Project Verification Plan, Traceability Matrix, and risk assessments (not necessary lead the execution).
20. Coordinate verification for the Project Manager during the verification phase of the project.
21. Accountable for the discrepancy tracking and management in the Verification phase.

Basic Requirements:

1. BS in Engineering (Chemical or Mechanical preferred)
2. Minimum of 5-years manufacturing and/or engineering experience in support of pharmaceutical or API (active pharmaceutical ingredient) networks

Additional Preferences:

1. Pharmaceutical process or project engineer experience
2. Strong project management skills
3. Ability to effectively facilitate conflict to resolution
4. Ability to influence all levels of the project and site personnel
5. Understanding of the capital project delivery process, A/E design activities, and the understanding of the available Lilly technical resources (user reps, Engineering Tech Center resources, and design specialists)
6. Demonstrated values that are consistent with the Lilly values
7. Able to frame complex decisions/analyses, facilitate to a decision, and implement according to the plan
8. Ability to create creditability and influence to align decision agreements between site(s), corporate engineering, A/E firm decision-makers, and stakeholders who have differing opinions
9. Experience facilitating issue resolution, anticipating scope changes, and implementing projects safely with quality, speed and value
10. Willingness to relocate and/or travel to locations outside of home state/country and have the demonstrated ability to work from long distances with little supervision

Additional Information:

1. Travel can be both domestic and international, on average about 25%, depending on the phase of the project
2. The potential of co-location at the A/E firm or the job site to support C&Q activities for periods of time could occur based on project needs