Night Shift Operator, Parenteral Operations (Aseptic Filling)

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Job description

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.

Organization Overview

For 140 years, Lilly has manufactured medicines that improve people's lives around the world. We produce our medicines using some of the most sophisticated manufacturing technologies and rigorous quality standards. Lilly Manufacturing strives for excellence in its process, standards, procedures and behaviors to develop medicines with safety first and quality always.

Position Description

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) Operators (Entry to Expert roles) 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. This position will require travel (2-4 week trips and/or 3-12 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. Operators will support 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.

Key Values / Objectives

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.
• Key liaison between operations and support functions.

Basic Qualifications/Requirements:

Time Commitments and Work Authorization

• Minimum education: High School Diploma or GED
• A valid drivers license
• Must Pass a "fitness for duty" physical exam
• 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.
• Must pass a vision exam and be free of color blindness
• Must be equivalent to 20/20 correctable close vision acuity

Addttional skills/preferences:

Experience with, completion of, or understanding of:

• We have several levels open for Operator which are based on the experience and education you bring.
• 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.
• 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
• STEM degree or certifications
• Aseptic filling, single use assemblies, isolator technology.
• Automated, semi-automated, and/or manual inspection.
• 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

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, 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 help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.

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