Operations Associate - Aseptic Process / Sterility Assurance Mentor at Eli Lilly and Company

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.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

Position Brand Description:

The Aseptic Process Mentor position in Operations is responsible for ensuring the aseptic techniques and practices are consistently executed across the Grade A/B production areas within the IPM site.  This role serves as a coach, mentor and subject matter expert for operations and process team members.  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 in the Grade A/B production areas, and working safely and accountable for supporting all HSE Corporate and Site Goals.
• Coach aseptic operations & EM personnel on the site’s Aseptic Intervention, Aseptic Process Simulation, Environmental Monitoring, Facility Cleaning and Disinfection, Gowning and Hygiene, and Sterility Assurance Risk Management.
• Lead & develop aseptic manufacturing training and qualification programs.
• Provide technical guidance on the floor regarding aseptic practices & techniques, including how to leverage SOPs, tools and best practices to optimize processes.
• Provide technical support for root cause investigations for sterility assurance programs.  Serve as a technical mentor supporting process team members through RCI and deviation documentation.
• Create, execute and / or review change controls to assess the impact of changes on aseptic practices and techniques to ensure operations personnel have appropriate procedural guidance, tools and design improvements for consistent execution.
• Partner with B5s of the Operations Teams to ensure feedback on aseptic practices is consistent and coaching is effectively shared with the aseptic operators.
• Develop as a subject matter expert on high-risk interventions across the aseptic filling lines.  Knowledgeable of low and medium risk interventions to provide appropriate level of coaching and technical oversight.
• Assess execution steps across the operations to ensure operations personnel have adequate training, procedural guidance, tools and design for consistent execution.  Develop and implement tools and processes as needed to support strong aseptic practices.  Look for opportunities to streamline execution while maintaining a state of compliance.
• Actively participate to Floor Observations in order to confirm correct aseptic technique/practices on the floor and mentor support functions personnel.  Most of these observations should occur from within the Grade B production areas or Grade C areas for the isolator production lines.  This will require Grade B gowning qualification.
• Analyze data from floor time observations, address trends if observed, assess potential opportunities for improvement at plant and or site level
• Continually educate self and others to drive continuous improvement for sterility assurance programs as well as aseptic techniques and practices.
• Participate in external forums/conferences to consistently benchmark internal aseptic practices/techniques with best practices within the industry.
• Support the onboarding of new aseptic operations personnel by developing aseptic practices/techniques training and assessment plans, then serving as trainer/assessor.
• Partner with external and global SMEs to develop an aseptic operations training program focused on aseptic practices & techniques for both RABS and Isolator production lines.  Train OJTs & B5s on this program and continuously assess to ensure continuity of practices.
• Partner with the PTL and SAT process team representative to develop agendas and content for aseptic forums.

Minimum Requirements:

• Bachelors Degree in Microbiology, Biology, Engineering or equivalent experience.
• 2+ years in parenteral manufacturing or equivalent experience.

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

Other Information:

• +8-hour days – Monday through Friday
• Off-hours work will be required to provide support for night/weekend shift personnel
• 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.
• Responsible for maintaining a safe work environment, working safely, and accountable for supporting all HSE Corporate and Site Goals.

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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.

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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