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.

　　Position Description

　　Company Overview

　　At Lilly, we unite caring with discovery to make life better for people around the world. We are a 140+ year strong global healthcare leader headquartered in Indianapolis, Indiana with manufacturing sites throughout the US, EU, and Asia. Our 35,000 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 are looking for people who are determined to make life better for people around the world and embody our company values of Integrity, Excellence, and Respect for People

　　Position Overview

　　Lilly is investing over $1 Billion to build a completely new, inspiring, and highly automated campus in Concord, North Carolina which will house warehousing & logistics, operations including parenteral, medical device assembly, and packaging, QC laboratories, and support teams to produce medicines for an unmet patient need.

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

　　During the project phase, the Process Team Lead (PTL), Utilities is responsible for staffing, training, and leadership of the utilities group supporting asset delivery, process development, operations readiness, start up, and validation which includes gray and clean utilities. This position will require travel domestically with the opportunity for travel internationally to collaborate and learn from sites who produce our medicines currently

　　After project completion, the PTL role is responsible for ensuring the group meets annual production goals as well as planning through 1-3 year horizons. They are expected to lead by example and provide coaching to others in the areas of safety, quality, operational excellence, compliance, and continuous improvement. The PTL will be responsible for leading their respective cross-functional process teams. This role includes oversight of third party Supervisors and Operators. Direct line supervision includes engineers.

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

　　Key Objectives / Deliverables

　　Integrity

　　Leading by example with a Safety first, Quality Always mindset. Comfortable with exercising and encouraging "Stop Work Authority" for all employees if there is a perceived unsafe or product impacting situation.

　　Lead/conduct area deviation and corrective action discussions with a cross-functional team from Engineering, Maintenance, Technical Services / Manufacturing Sciences (TS/MS), Quality, and Health, Safety, and Environmental (HSE) functional groups

　　Present operations investigations and procedures to Regulatory Agencies and act as a Subject Matter Expert (SME) for related inspections, tours, and discussions.

　　Excellence

　　Ensure consistency of operations across shifts through active engagement on the shop floor, Gemba walks, and Practice vs. Procedure evaluations.

　　Maintain and communicate metrics to measure performance against business objectives and make necessary changes to continuously improve.

　　Participate in the development and implementation of strategies focused on the following initiatives: Continuous Improvement, Root Cause Analysis (RCA), Failure Modes Effect Analysis (FMEA), Operational Standards for Supply Chain Excellence (OSSCE).

　　Understand and influence the manufacturing control strategy for their area.

　　Respect for People

　　Support Site Leadership to build a diverse and capable site organization while delivering area operational procedures, quality processes and controls for the Utilities areas.

　　Provide leadership and develop objectives to deliver Business Plan goals as it relates to finances, safety, quality, stewardship, and people.

　　Act as a primary contact for other areas such as Production Planning, HR, Quality Assurance, Engineering and Environmental/Safety.

　　Leading the Utilities Process Team, a cross functional group charged with making medicine, continuous improvement, and site support.

　　Requirements (Education, Experience, Training)

　　Basic Qualifications

　　Bachelor's degree in a STEM or pharmaceutical related field of study.

　　At least 7 years working in the pharmaceutical industry.

　　Solid understanding of basic requirements of regulatory agencies such as the FDA, EMEA, DEKRA, and/or OSHA.

　　Excellence in; interpersonal, electronic, written, and oral communication

　　Strong technical aptitude and ability to train and mentor others

　　Time Commitments, Environment, and Work Authorization

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

　　Ability to work 8 hours per day Monday through Friday with overtime as required to meet key objectives.

　　Position will involve frequent business trips domestically with potential international travel to support testing of equipment at vendor sites, visit Lilly sites to learn and collaborate, and to build global network.

　　Travel domestically and internationally, up to approximately 20% of the year to learn and network with colleagues.

　　Preferred attributes but not required

　　Experience with, completion of, or understanding of:

　　cGMP standards and FDA (or other industry) guidelines for production

　　Aseptic filling, single use assemblies, isolator technology.

　　Highly automated equipment

　　Creation of standard operating procedures, work instructions, and training documentation.

　　Equipment & Facility design documentation reviews

　　Facility, equipment, or system start up.

　　Qualification and process validation experience.

　　Continuous improvement methodologies and mindset – lean, six sigma, etc.

　　Documentation, deviation and change management systems (e.g., Trackwise. Veeva, QualityDocs, Kneat)

　　This job specification is intended to provide a general overview of the job requirements at the time it was prepared.  The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job specification.  As always, you should consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position.

　　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 ( [email protected] ) 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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