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:

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 validationPrepare, 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 complianceBenchmark with sites in the network to drive technical consistency and knowledge sharingServe as interface with upstream suppliers and Dry product networkOwn cleaning batch records and revisions, ensuring they are current and accurateSupport equipment commissioning and qualification activities, as requiredCollaborate with Commercialization Project Manager as well as cross-functional tech transfer team members to commercialize new products in IDAPUnderstand the scientific principles required for Dry Packaging operationsSupport regulatory submissions as neededUnderstand and implement global requirements and standards into the Dry Process TeamProvide technical leadership for the Process Team for cleaning activitiesProvide off hours support as needed

Basic Requirements:

Bachelor’s degree or equivalent in a STEM disciplineMinimum 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 practicesClear understanding of cGMPsExperience in pharmaceutical manufacturingGood teamwork and interpersonal skillsRoot Cause Investigation experienceExperience in technical leadershipOral and written communication skills that demonstrate effective communication with all levels of an organization

Other Information:

Some travel