Lead Operator, Aseptic Filling (Day Shift)

Position Description

Lilly is investing over $1 Billion to build a new, highly automated campus in Concord, North Carolina, increasing capacity in parenteral (injectable) medications, device assembly, and packaging operations. During the project phase, the Parenteral (PAR) Lead Operator will support start up activities required to bring the aseptic isolator barrier filling area into service, become the expert within their assigned area, and educate their team in the proper operation of the facility. After the project phase is complete, this role will ensure continuous supply of medicines by expertly running the process, troubleshooting, and collaborating cross-functionally.

Integrity

• 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.

Excellence

• Technical leader: key resource for troubleshooting and primary point of contact for issue escalation on the shop 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.
• Assist in checking execution documentation (Electronic Batch Record, SAP, Cleaning Logs).
• Drive key departmental objectives including improving safety performance, reducing deviations, improving productivity, and training compliance.

Respect for People

• Support Site Leadership to build a diverse and capable site organization by delivering area operational procedures, quality processes and controls for the PAR areas.
• Assist Supervisor in development and performance evaluations of shift operators.
• Act as backup for Supervisor.
• Key liaison between operations and support functions.

Education, Experience, and Skills

• Minimum education: High School Diploma or GED
• Ability to effectively communicate (electronically, written and verbal)
• Flexibility - the ability to troubleshoot and triage challenges
• Computer proficiency (desktop software, MS office)
• Leadership and the ability to train / educate team members
• Aseptic filling, single use assemblies, isolator technology
• Highly automated equipment (inspection, packaging, filling, assembly, etc.)
• Knowledge of current Good Manufacturing Practices (cGMPs)
• Experience in operations/manufacturing environments within pharmaceutical, medical device, or food processing industries
• Manufacturing Execution Systems and electronic batch release
• Continuous improvement (Lean, Six Sigma methodologies)
• SAP, Electronic Batch Records
• STEM degree or certifications

Time Commitments and Work Authorization

• Must be able to work the day shift schedule (6am to 6pm on a 2-2-3 schedule)
• Ability to work overtime as required
• Ability to wear safety equipment (glasses, shoes, gloves, etc.)
• Ability to work and gown in a cleanroom (Grade C, ISO 8) environment
• Ability to participate in professional development opportunities (team coursework such as classes through RCCC)
• 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.