Filling Lead Operator (Nights)

Role Summary

Filling Lead Operator (Nights) at Lilly. Responsible for leading isolator filling operations, supporting project startup activities, and ensuring continuous, safe, and compliant production when in operation. Leads training, oversees daily activities to meet capacity plans, and acts as a technical and administrative resource on the manufacturing floor.

Responsibilities

• Provide leadership on manufacturing floor ensuring high level of safety, quality, and productivity to maintain reliable supply of products to patients.
• Responsible for maintaining a safe work environment, exemplifying safe working practices, and being accountable for supporting HSE goals.
• Act as both administrator and technical leader for operations.
• Set a good example through demonstrated knowledge of procedures, compliance with quality systems, and teaching of proper techniques.
• Acts as key resource for troubleshooting and functions as the primary point of contact for issue escalation on the production floor.
• Responsible for administering technical training and ensuring all operators are trained to perform tasks.
• Operate the equipment and perform activities as required to meet production schedule.
• Assists in checking execution documentation (Electronic Batch Record, SAP, Cleaning Logs).
• Drives key departmental objectives including improving safety performance, reducing deviations, improving productivity, and training compliance.
• Support Site Leadership to build a diverse and capable site organization by delivering area operational procedures, quality processes, and controls for the isolator area.
• Assist Supervisor in development and performance evaluations of shift operators.
• Act as backup for Supervisor.
• Key liaison between operations and support functions (Maintenance, Engineering, TS/MS, Quality).

Qualifications

• High School Diploma or equivalent
• Minimum 2 years relevant experience in pharmaceutical or medical device manufacturing
• Basic digital literacy (desktop software) is required
• Must be able to lift 45lbs
• Ability to work 12-hour shifts (2-2-3 schedule) with additional overtime as the need arises
• Knowledge of current Good Manufacturing Practices (cGMPs)
• Previous experience working in a Grade C environment with isolator equipment
• Qualified candidates must be legally authorized to be employed in the United States

Skills

• Participation in media fill qualifications
• Scientific/technical degrees or certifications
• Previous experience using solution filling equipment and/or isolator technology
• Previous experience with Manufacturing Execution Systems
• Flexibility to support a major capital project, with an aggressive delivery schedule
• Knowledge of lean manufacturing principles
• High level of attention to detail
• Ability to troubleshoot and escalate issues as necessary on the production floor

Education

• Not specified beyond required High School Diploma or equivalent

Additional Requirements

• None beyond listed qualifications