Lead Technician - Sterility Assurance TSMS (Day Shift)

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. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

Position Brand Description:

Lilly unites caring with discovery to create medicines that make life better for people around the world.  Lilly is a Fortune 500 company that has been in operation for over 140 years.  We make medicine with safety first and quality always while living our company values of Integrity, Excellence, and Respect for People.

Lilly is designing and building a new state of the art Parenteral, Device Assembly, and Packaging Facility located at the Research Triangle Park (RTP) in North Carolina.  This is an exciting opportunity to help build and operate a state-of-the-art manufacturing site and Quality System from the ground up. 

The Lead Technician -Technical Services / Manufacturing Science (TS/MS) - SAT role provides continuous support of the parenteral operations to enhance and improve assurance of sterile product manufacture. This role works closely with Operations and Environmental Monitoring personnel during all aseptic production activities and is responsible for addressing any sterility or product quality related questions during manufacturing.

The Lead Technician will work closely with cross-functional teams to lead troubleshooting and problem solving initiatives related to sterility assurance and contamination risks in the production area(s). You will address all unplanned events within the classified areas that may require remediation or aseptic interventions to be executed.  You will be expected to continue to develop a high level of expertise in aseptic processing within TS/MS whilst supporting the RTP Parenteral Facility.  As designated by management, additional support for qualification/validation activities or other routine responsibilities within the TS/MS group could be assigned. 

Key Objectives / Deliverables:

• The objective of the role is actively coaching, auditing, and communicating within the Aseptic Processing areas for the majority of shift. Must be an extension of Sterility Assurance within the classified areas to monitor and reinforce best aseptic practices.
• Ability to identify, report on, and lead resolution of events related to the maintenance of aseptic conditions within clean rooms with a focus on Sterility Assurance during manufacturing operations.
• Promptly communicates with Operations regarding aseptic techniques and behaviors of personnel.
• Gather, organize & analyze data to develop solutions & alternative methods of proceeding compliantly.
• Conduct periodic internal reviews or audits to ensure that procedures are followed.
• Lead and organize remediation activities from day-to-day unplanned events or shutdown activities.
• Lead, coach and mentor personnel on aseptic techniques and practices during manufacturing activities and when executing smoke studies or other qualification activities.
• Correcting and communicating proper aseptic technique when needed and communicating with supervisors as needed on corrected behaviors.
• Be a point of contact for aseptic operations and bioburden control.
• Provide technical support for non-routine investigations (e.g., deviations, complaints), including leading the execution of required studies. 
• Lead or support the delivery of training on aseptic practices, techniques, and interventions.
• Execute or assist in qualification/validation activities to support the bioburden control of the facility or equipment
• Support other routine responsibilities with the TS/MS group, as assigned by management.
• Ensure a safe working environment through compliance with safety rules and improve safety culture by actively participating in safety-related activities.

Minimum Requirements:

• High school diploma or GED equivalent
• Minimum 5 years of pharmaceutical experience supporting cGMP manufacturing

Additional Preferences:

• Strong knowledge of parenteral drug product manufacturing
• Strong interpersonal and teamwork skills
• Strong self-management and ability to work independently
• Oral and written communication skills that demonstrate an ability to effectively communicate with all levels of the organization
• Ability to effectively prioritize and conduct a variety of tasks and requests
• Experience in aseptic processing, environmental monitoring, microbiology, equipment qualification and validation
• Experience with execution of and/or observation of aseptic interventions
• Ability to analyze data and solve problems
• Demonstrated strong written and verbal communication skills
• Previous experience with deviation and change management systems, including Trackwise
• Previous experience with Kneat

Other Information:

• The position is 12 hr. shifts on a 2-2-3 rotation. Must be flexible in providing support to accommodate other inputs (production schedules, shutdowns, etc.).  Occasional extended hour and / or off-hour work may be required.
• Position will be based out of RTP site with ability to travel to Indianapolis and other global Lilly sites as required

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 (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and 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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