Eli Lilly and Company
Location: Indiana,PA, USA
Date: 2024-12-12T08:52:13Z
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 andmanagement 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.Organization Overview:Lilly is currently constructing an advanced manufacturing facility for production of API (Active Pharmaceutical Ingredient) 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, including new modalities. This is a unique opportunity to be a part of the startup team for a greenfield manufacturing site, and the successful candidate will help to build the processes and facility to enable a successful startup into GMP manufacturing operations.Position Brand Description:The Utility Operator is directly responsible for ensuring that the generation and distribution of the utility services is provided without interruption of service to support the needs of the facility. The Utility Operator for Plant Utilities will be responsible for gray, clean, and plant utilities. The role is responsible for the direct execution of utility operations (per SOPs and operational execution instructions) in order to safely and compliantly support the manufacturing of high-quality medicine.In the project delivery phase and startup phase of the project (startup expected 2025 to 2027), roles will be fluid and dynamic as we endeavor to support the project delivery, build a new organization, develop and implement the necessary systems and business processes required to support GMP operations, and build the site culture. This will require significant collaboration, creativity and resilience as the site grows to a full scale GMP manufacturing through start up.Responsibilities:Ensure utility operations maintains compliance with all regulatory requirements at all times.Ensure utility areas appropriately support the execution of the production plan for the site.Utility Operator Systems: Water Systems, Boilers, Nitrogen System, Chillers, Instrument Air, Cooling Towers, Fire Water Pumps.Carry out daily monitoring testing and cleaning duties as assigned on the above listed systems to ensure equipment and systems are in good operating conditions and they are maintained in accordance with local and corporate regulatory requirements.Understand Health, Safety & Environmental-regulated environment and application of Health & Safety/Process Safety standards in order to execute key/critical GMP duties.Understand other area processes & their operational hazards and being able to react appropriately.Monitoring and collecting data on equipment use and performance i.e. trying to anticipate potential equipment reliability problems.Working with Maintenance and Technical Support to respond appropriately to potential utility supply upsets or equipment failure.Contacting the appropriate help if there is a problem or an event (spill/deviation/incident) during processing.Communication to other shifts regarding the status of the area operations and details of any issues/problems that have occurred at handover.Actively participating in assigned building & area operations such as safety audits, procedure co-ordination, housekeeping and improvement projects.Training and qualification on all specified unit operations within the building.Identify concerns for informal or formal discussion (crew meetings, safety representative).Know and follow cGMP practices, safe work habits, plant dress code, hygiene standards, and housekeeping requirements unique to the work area and job classification.Basic Requirements:High School Diploma or equivalent.Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.Previous experience working in a manufacturing environment.Completion of Post Offer Exam or Completion of Work Simulation if applicable.Additional Preferences:Previous experience in facility/area start-up environments.Previous experience in utility operations or directly supporting a pharmaceutical manufacturing operation.Basic computer skills (desktop software) are required.Solid understanding of FDA guidelines and cGMP requirements.Excellent interpersonal, written and oral communication skills.Strong organizational skills and ability to handle and prioritize multiple requests.Knowledge of lean manufacturing principles.Emergency Response Experience: Industrial, military, volunteer, career firefighter; Indiana State or IFSAC Certification - Fire 1, Hazmat Technician.Additional Information:Ability to work 12-hour day or night shifts.Ability to work flexible schedules during startup period.Ability to work overtime as required.#J-18808-Ljbffr
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