Engineer - HVAC
- 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
- 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
- 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
- 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
- Demonstrated high level of understanding of engineering concepts, 1st principles, and engineering functional standards
- Strong technical aptitude and ability to train and mentor others
- Previous start up experience
- Engineering experience in the pharmaceutical industry
- Previous equipment commissioning experience
- Engineering experience with manufacturing plant utilities
- Project management experience
- Experience with maintenance and computerized maintenance management systems (CMMS)
- Previous experience with deviation and change management systems including Trackwise
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