Aseptic Process Mentor

1 month ago

Indianapolis, United States Eli Lilly and Company Full time

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.

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 39,000 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’re looking for people who are determined to make life better for people around the world. #WeAreLilly

Position Brand Description: 

The Aseptic Process Mentor position in Technical Services / Manufacturing Sciences – Sterility Assurance Technology (TS/MS – SAT) is responsible for ensuring the training on SAT owned topics is appropriate and sufficient as well as providing coaching and mentoring to operations and support staff. This position will also be responsible for support of the Floor Time Observation Program in reference to Sterility Assurance related topics and proposing continuous improvement initiatives with site impact and alignment. The Aseptic mentor will make sure Aseptic practice on the floor are aligned with approved procedures.

Key Objectives / Deliverables:

Responsible for maintaining a safe work environment, leading safety initiatives, and working safely and accountable for supporting all HSE Corporate and Site Goals.Coach personnel who directly support aseptic operations on the site’s Aseptic Intervention, Aseptic Process Simulation, Environmental Monitoring, Facility Cleaning and Disinfection, Gowning and Hygiene, and Sterility Assurance Risk Management.Lead aseptic manufacturing training and qualification programs.Provide technical guidance on the floor for sterility assurance programs.Lead or provide technical support for root cause investigations for sterility assurance programs.Create, execute and / or review change controls related to sterility assurance programs.Actively participate to Floor Observations in order to confirm correct aseptique practices on the floor and mentor support functions personnel.Analyze data from floor time observations, address trends if observed, assess potential opportunities for improvement at plant and or site levelExecute or assist in the development of process and facility monitoring strategies that focus on areas of highest microbial risk.Continually educate self and others to drive continuous improvement for sterility assurance programs.Participate or provide guidance for sterility assurance programs during regulatory audits.

 

Additional Preferences: 

Strong technical writing 

Strong presentation skills 

Teamwork / interpersonal skills ability to effectively influence 

Experience with data trending and analysis 

Analysis and problem-solving skills 

Quality orientation 

 

Basic Requirements: 

Bachelor’s Degree in Microbiology, Biology or equivalent experience. 

Minimum 3-5 years on the floor experience in aseptic manufacturing, parenteral preferred or equivalent experience.

Other Information:  

8-hour days – Monday through Friday 

Overtime will be required 

Work in a dynamic and fast-paced environment 

Applicant will work in various areas within the Parenteral Site.  Some allergens are present. 

Applicant will be required to become aseptic certified and to enter in aseptic manufacturing areas for support of activities.  

Mobility requirements should be considered when applying for this position 

Responsible for maintaining a safe work environment, working safely, and accountable for supporting all HSE Corporate and Site Goals. 

On call rotation (by phone) may be required  

 

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 ( Lilly_Recruiting_Compliance@lists.lilly.com ) 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.

#WeAreLilly

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