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 OverviewAt 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:The Technical Services and Manufacturing Sciences (TS/MS) Representative for Cleaning Validation is a technical position that supports, develops and implements a technical agenda for their area of responsibility. The TS/MS Representative is responsible for providing technical leadership for activities within Indianapolis Device Assembly & Packaging (IDAP), including new product commercialization and commercial product support. This position focuses specifically on Dry Packaging which includes bottle and blister card filling and packaging for tablets and capsules. Primary objectives include cleaning validation, cleaning compliance, continuous improvement of processes, and supporting day-to-day operations of Process Teams.
Key Objectives / Deliverables:- Execute the technical agenda for the Dry Packaging cleaning and cleaning validation
- Prepare, review, and approve, as required, relevant technical documents such as: annual product reviews, change controls, regulatory submissions, deviations, validations, procedures, PFDs, PFMEAs, etc.
- Lead technical projects to improve cleaning processes and compliance
- Benchmark with sites in the network to drive technical consistency and knowledge sharing
- Serve as interface with upstream suppliers and Dry product network
- Own cleaning batch records and revisions, ensuring they are current and accurate
- Support equipment commissioning and qualification activities, as required
- Collaborate with Commercialization Project Manager as well as cross-functional tech transfer team members to commercialize new products in IDAP
- Understand the scientific principles required for Dry Packaging operations
- Support regulatory submissions as needed
- Understand and implement global requirements and standards into the Dry Process Team
- Provide technical leadership for the Process Team for cleaning activities
- Provide off hours support as needed
Basic Requirements:- Bachelor's degree or equivalent in a STEM discipline
- Minimum 2 years of experience, with at least 1 year with cleaning/cleaning validation in a GMP environment
Additional Preferences:- Technical / Scientific knowledge of cleaning regulatory requirements and practices
- Clear understanding of cGMPs
- Experience in pharmaceutical manufacturing
- Good teamwork and interpersonal skills
- Root Cause Investigation experience
- Experience in technical leadership
- Oral and written communication skills that demonstrate effective communication with all levels of an organization
Other Information: Some travel <10% (domestic and international) may be 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 ( 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 proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$66,000 - $171,600
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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