Lead Operator, Parenteral Operations

Job Opportunity at Lilly

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 give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.

Lilly is entering an exciting period of growth, and we are committed to delivering innovative medicines to patients around the world. Lilly is investing over $1 Billion to build a completely new, inspiring, environmentally conscious, and highly automated campus in Concord, North Carolina. This brand-new campus will utilize the latest technology to increase the company's capacity in parenteral (injectable) medications, device assembly, and packaging operations. This is an exciting and once-in-a-lifetime opportunity to build and operate a new site.

If you ever wanted to have a direct impact building a team's culture and in how the team operates, now is the perfect opportunity!

During the project phase, the Parenteral (PAR) Lead Operator will support start up activities required to bring the area into service which may include formulation, aseptic isolator barrier filling, and visual inspection. They will become the experts within their assigned area and educate their team in the proper operation of the facility. The Lead roles are expected to become the leaders for the PAR equipment and process and will lead the training of new staff. This position will require travel (24-week trips and/or 312-month short term assignments) domestically with the opportunity for travel internationally to collaborate, train with, and learn from sites who currently produce our medicines.

After project phase is complete, this role will be responsible for ensuring continuous supply of our medicines by; expertly running the process, troubleshooting, and collaborating cross-functionally, and holding all to our safety first / quality always mindset. Lead Operators will coordinate daily activities to meet capacity plans while developing their own and our 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.

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 leaders 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 functions as the 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.
• 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.

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.
• (Lead role) 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

• We have several levels open for Operator which are based on the experience and education you bring.
• 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).

Time Commitments and Work Authorization

• 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 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) Depending on the candidate's experience, the position may require a short-term assignment of 3-12 months domestically or internationally to train and be certified on existing processes and establish global contacts. There may also be a requirement for short (less than 1 month) travel to support equipment testing at the manufacturer's factory.
• 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.

Experience with, Completion of, or Understanding of:

• (Senior and Lead roles) Leadership and the ability to train / educate team members
• Automated, semi-automated, and/or manual
• Aseptic filling, single use assemblies, isolator technology.
• Automated, semi-automated, and/or manual inspection experience is required
• 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 (inspection, packaging, filling, assembly, etc.)
• SAP, Electronic Batch Records

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $25.60 - $42.67. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for 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; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.