Lead Operator - Aseptic Filling (Day Shift)

Lilly • Concord, NC

13d • $27 - $40 • Onsite

About The Position

The Lead Operator - Aseptic Filling will support the start-up of a new, highly automated manufacturing campus in Concord, North Carolina. During the project phase, the role will help bring the aseptic isolator barrier filling area into service, become an expert in the assigned area, educate the team on facility operations, and lead training for new staff. Once the project phase is complete, the Lead Operator will run and troubleshoot the process, collaborate across functions, coordinate daily activities to meet capacity plans, and help ensure a continuous supply of medicines while maintaining a safety-first and quality-always mindset.

The role provides leadership on the manufacturing floor and serves as both an administrative and technical leader for operations. It is a key resource for troubleshooting and issue escalation, administers technical training, supports production execution and documentation review, and contributes to departmental goals involving safety, quality, productivity, and training compliance. The Lead Operator also supports operational procedures and quality controls, assists the Supervisor with shift-operator development and performance evaluations, serves as a backup for the Supervisor, and acts as a liaison between operations and support functions. The position offers opportunities for growth into future leadership and technical roles.

Requirements

• High school diploma or GED.
• At least 5 years of experience working with automated equipment in a GMP/cleanroom environment.
• At least 3 months of leadership experience and the ability to train or educate team members.
• At least 3 months of experience working with computers, including desktop software, Microsoft Office, HMIs, or electronic batch records and systems.
• Authorization to work in the United States on a full-time basis; the employer will not sponsor work authorization or visas for this role.
• Ability to work A shift, 6 a.m. to 6 p.m. on a 2-2-3 schedule.
• Must pass a fitness-for-duty physical exam.
• Ability to work overtime as required.
• Ability to wear safety equipment such as glasses, shoes, and gloves.
• Ability to work and gown in a Grade C, ISO 8 cleanroom environment.
• Ability to participate in professional development opportunities, including coursework.

Nice To Haves

• STEM degree or certification.
• Effective electronic, written, and verbal communication skills.
• Flexibility and ability to troubleshoot and triage challenges.
• Knowledge of aseptic filling, single-use assemblies, or isolator technology.
• Automated, semi-automated, or manual inspection experience.
• Knowledge of current Good Manufacturing Practices (cGMPs).
• Experience in operations or manufacturing environments.
• Experience in the pharmaceutical, medical device, or food processing industries.
• Knowledge of Manufacturing Execution Systems and electronic batch release.
• Continuous improvement experience, including Lean or Six Sigma methodologies.
• Experience with highly automated equipment such as inspection, packaging, filling, or assembly equipment.
• Experience with SAP or Electronic Batch Records.

Responsibilities

• Support start-up activities to bring the aseptic isolator barrier filling area into service.
• Become an expert in the assigned area and educate the team in proper facility operation.
• Lead training of new staff and administer technical training to ensure operators are qualified to perform tasks.
• Provide leadership on the manufacturing floor to support safety, quality, productivity, and reliable product supply.
• Maintain a safe work environment, model safe practices, and support HSE goals.
• Serve as a technical resource for troubleshooting and the primary point of contact for shop-floor issue escalation.
• Operate equipment and perform manufacturing activities as needed to meet the production schedule.
• Assist in checking execution documentation, including Electronic Batch Records, SAP, and cleaning logs.
• Drive departmental objectives, including improving safety performance, reducing deviations, improving productivity, and maintaining training compliance.
• Support site leadership by delivering area operational procedures, quality processes, and controls for the parenteral areas.
• Assist the Supervisor with development and performance evaluations of shift operators and act as a backup for the Supervisor.
• Serve as a key liaison between operations and support functions.
• Coordinate daily activities to meet capacity plans and develop individual and team capabilities.

Benefits

• Company bonus, depending in part on company and individual performance.
• Eligibility to participate in a company-sponsored 401(k).
• Pension.
• Vacation benefits.
• Eligibility for medical, dental, vision, and prescription drug benefits.
• Flexible benefits, such as healthcare and dependent day care flexible spending accounts.
• Life insurance and death benefits.
• Certain time-off and leave-of-absence benefits.
• Well-being benefits, including an employee assistance program, fitness benefits, and employee clubs and activities.
• Employee resource groups open to all employees.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED