Engineer - HVAC

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.

Lilly unites caring with discovery to create medicines that make life better for people around the world.  Lilly is a fortune 500 company that has been in operation for over 140 years.  We make medicine with safety first and quality always while living our company values of Integrity, Excellence, and Respect for People.

Lilly is designing and building a new state of the art Parenteral, Device Assembly, and Packaging Facility located in Concord, North Carolina.  This is an exciting opportunity to help build and operate a state-of-the-art manufacturing site and Quality System from the ground up.

The HVAC Engineer is the site Subject Matter Expert (SME) for site HVAC (GMP and non GMP) and the ancillary systems associated within the facilities.  During the project phase, the HVAC Engineer will be a key player in the cross functional project team in charge of the construction, commissioning, qualification, start-up and operational readiness of all HVAC systems.  During the day-to-day operation, the HVAC Engineer will be responsible for effectively, reliably, and cost effectively operating the site’s HVAC (GMP and non-GMP) and ancillary systems associated within the facilities, maintaining all these systems in a state of compliance, in-control, and fit for use, capable of meeting all site needs. The HVAC Engineer will also be responsible for driving continuous improvement initiatives and local capital investment.

Responsibilities:

• Be the SME with a deep technical expertise in all systems under his/her responsibility (GMP and non-GMP HVAC and ancillary systems associated within their facilities), understanding their applications in pharmaceutical manufacturing, understanding flow charts and process parameters, and awareness of industry trends.
• Ensure the assigned processes are in alignment with the Industry and Lilly Standards
• Support risk assessment exercises using the different tools available (e.g. FMEA)
• Participate as required in teams, committees, or other groups and/or individually to achieve the departmental, site and/or company goals

Initial project asset delivery phase and future local capital investment:

• Lead or participate in projects/changes for all the systems under his/her responsibility including Design, verification activities (IV/OV/PQ), as user representative for capital projects or delivery agent for local projects.
• Develop the proper documentation (URs, Specification, test cases, etc..) to demonstrate that systems are properly installed, qualified and started up and that remains in a controlled state
• Contribute to the process resource assessment, capital plans, expense budgets, and prioritize appropriate

Daily Support to operations:

• Monitor utility systems and maintain KPI’s to assure that they are operating properly, in compliance with requirements.
• Provide written instructions for the proper way to operate and maintain the equipment and process to assure that the system operates within the controlled parameters
• Implement efficient and effective maintenance and reliability techniques,
• Apply problem solving skills by leading equipment failures troubleshooting, demonstrating RCA lead investigator proficiency and guide operations personnel in the resolution of process issues.
• Provide customer consultation and notifications on issues that involve utilities areas assigned
• Assure that all necessary items are identified on the proper tracking systems, and make sure that items are completed by the required date
• Provide technical assistance as necessary to maintenance, and operations personnel
• Support internal and external inspections and investigations (including Quality and HSE)
• Maintain efficient communications with appropriate site customer groups
• Proficiency with the Trackwise and CAPA systems

Basic Requirements:

• Education Requirements: Bachelor’s degree in Engineering (prefer ME, EE, Chem E).
• Technical experience of HVAC and Utilities
• Demonstrated office software skills (Word, Excel, PowerPoint, Outlook, UMS, data historian) and collaboration sites
• Excellent interpersonal, written and verbal communication skills
• Knowledge of cGMP
• Demonstrate