Lead Operator - Aseptic Filling; Night Shift

Overview

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 and management of disease, and give back to our communities through philanthropy and volunteerism. We put people first and are looking for individuals determined to make life better for people around the world.

Company overview:
Lilly is a 140+ year strong global healthcare leader with manufacturing sites throughout the US, EU, and Asia. Our 35,000 employees work to advance medicines and improve patient outcomes while contributing to communities through philanthropy and volunteerism.

Lilly is entering an exciting period of growth and is investing to build a new, environmentally conscious, highly automated campus in Concord, North Carolina. This campus will increase capacity in parenteral (injectable) medications, device assembly, and packaging operations. This is an opportunity to build and operate a new site.

If you ever wanted to have a direct impact on building a team’s culture and operations, this is a perfect opportunity.

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. They will become experts within their assigned area and educate the team in proper operation of the facility. Lead roles are expected to become leaders for the PAR equipment and process and will lead the training of new staff.

After the project phase is complete, this role will be responsible for ensuring continuous supply of medicines by expertly running the process, troubleshooting, collaborating cross-functionally, and upholding safety and quality as core principles. Lead Operators will coordinate daily activities to meet capacity plans while developing their own and the team’s capabilities.

As a site leader and expert at our growing site, you’ll have significant opportunities for growth into future leadership and technical roles.

• 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 supporting HSE goals.
• Act as administrator and technical leader for operations. Set a good example through knowledge of procedures, adherence to quality systems, and teaching proper techniques.

• Technical leader:
  Key resource for troubleshooting and the primary point of contact for issue escalation on the shop floor.
• Administers technical training and ensures all operators are trained to perform tasks.
• Operates equipment and performs activities 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 ensuring training compliance.

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

• 5+ years of experience working with automated equipment in a GMP/cleanroom environment
• Leadership experience and the ability to train/educate team members
• Minimum education:
  
  High School Diploma or GED
• Ability to effectively communicate (electronic, written and verbal)
• Flexibility to troubleshoot and triage challenges
• Computer proficiency (desktop software, MS Office)

• Must be able to work B shift (6pm to 6am on 2-2-3 schedule)
• Must pass a fitness-for-duty physical exam
• Ability to work overtime as required
• Ability to wear safety equipment (glasses, shoes, gloves, etc.)
• Ability to gown in a cleanroom (Grade C, ISO
  8) environment
• Ability to participate in professional development opportunities (team coursework such as classes through RCCC)
• 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 or visas for this role.

• STEM degree or certification
• Knowledge of aseptic filling, single-use assemblies, isolator technology
• Automated, semi-automated, and/or manual inspection experience
• Knowledge of current Good Manufacturing Practices (cGMPs)
• Experience in operations or manufacturing environments
• Pharmaceutical, medical device or food processing industries
• Manufacturing Execution Systems and electronic batch release
• Continuous improvement (Lean, Six Sigma methodologies)
• Highly automated equipment…