Lead Process Technician - Filling

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:

At Lilly, we serve an extraordinary purpose. For more than 140 years, we have worked tirelessly to discover medicines that make life better. These discoveries start in Lilly Research Laboratories, where our scientists work to create new medicines that will help solve our world's greatest health challenges.

Lilly is designing and building a new state of the art Parenteral, Device Assembly, and Packaging Facility in Raleigh-Durham North Carolina. This is an exciting opportunity to help build a state-of-the-art facility and Quality System from the ground up.

Responsibilities:

This role will be pivotal in the startup of the syringe filling lines for the new Lilly RTP facility. This is a great opportunity for an experienced filling technician to develop technical skills, improve leadership skills, and gain a firm understanding of all the activities related to facility/process startup.

During the project phase, the Lead Filling Technician - Operations will support commissioning/qualification activities required to bring filling lines, utilizing isolator technology, into service as well as supporting site operational readiness activities. This position will require domestic travel with the opportunity for international travel based on program need. This role is expected to become a subject matter expert for the filling equipment/process and will be directly involved with training future new hires.

After project phase completion, this role will be responsible for line leadership, daily operations, development of operators, ensuring compliance with all policies, procedures, and ensuring resources are scheduled accordingly per the daily production plan.

Key Objectives

• Provide commissioning, qualification, and operational readiness support during project phase.

• Support Site Leadership to build a diverse and capable site organization by delivering area operational procedures, quality processes and controls for the Parenteral Filling area.

• Provide leadership on manufacturing floor ensuring high level of safety, quality, and productivity to maintain reliable supply of products to patients.

• 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.

• Assist Supervisor in development and performance evaluations of shift operators.

• Key liaison between operation and support functions.

• A Lead Technician is a "working leader" by operating the equipment and leading the shift operations as required to meet production schedule.

• Assists in checking execution documentation (PMX, SAP, Cleaning Logs, etc.)

• Drives key departmental objectives including improving safety performance, reducing deviations, improving productivity, and training compliance.

• Lead Technicians are the back up for the Supervisor.

Basic Requirements:

• High School Diploma or equivalent

• Minimum 3 years relevant experience, (education may be substituted for experience with manager discretion)

• Must Pass a "fitness for duty" physical exam

Additional Skills/Preferences:

• 5+ years relevant experience preferred

• Scientific/technical degrees or certifications

• Strong understanding of current Good Manufacturing Practices (CGMPs)

• Previous experience working in operations/pharmaceutical industry

• Previous experience utilizing solution filling equipment and/or isolator technology

• Previous experience performing aseptic process simulation/media fill

• Previous experience performing airflow pattern testing smoke studies

• Previous experience with Manufacturing Execution Systems and electronic batch release.

• Knowledge of lean manufacturing principles

• Demonstrated leadership skills

• Demonstrated ability to train and coach others

• Ability to effectively communicate (written and verbal)

• Flexibility and problem-solving skills

• Basic computer skills (desktop software) are required.

• Ability to work 12-hour shifts on days (2-2-3 schedule)

• Ability to work overtime as required

• Ability to travel up to >50% of the time during Asset Delivery and < 5% after startup

Additional Information:

• The position is for the Lilly Research Triangle Park site and during the project phase will allow for a flexible working environment will the ability to periodically work remotely based on the project phase and site activities.

• Position may require a short duration assignment of 2-6 months in Indianapolis to establish specific device knowledge, establish global contacts, and provide production support. Additionally, this position may require short (less than 1 month) international travel for training and/or process support.

• Ability to wear safety equipment (safety glasses, safety shoes, protective gloves etc.)

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.

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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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