Lead Operator - Utilities

Lilly • Lebanon, IN

30d • Onsite

About The Position

The Lead Operator for Utility Operations 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 Lead Operator for Utility Operations 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, 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.

Requirements

• High School Diploma or equivalent
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization and visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.
• Completion of Post Offer Exam or Completion of Work Simulation if applicable.
• Minimum 3 years previous experience in utility operations

Nice To Haves

• Previous experience in facility/area start-up environments
• Ability to assume leadership and prioritize daily priorities without direct supervision
• 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

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.
• 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.
• Enter Trackwise events, participate in and lead CAPA investigations
• Troubleshoot and diagnose process problems and take appropriate actions to minimize deviations or site impact
• 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.

Benefits

• company bonus (depending, in part, on company and individual performance)
• company-sponsored 401(k)
• pension
• vacation benefits
• medical, dental, vision and prescription drug benefits
• flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
• life insurance and death benefits
• certain time off and leave of absence benefits
• well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED
• Number of Employees: 5,001-10,000 employees