Advisor - Cleaning Validation – TS/MS

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.

Position Brand Description:

The Technical Services/Manufacturing Sciences Organization provides scientific leadership to all manufacturing operations globally. This position is designed to work across all networks, manufacturing sites, and functions within Lilly Manufacturing and Quality to ensure effective, robust, scientifically based, and compliant validation of cleaning processes. Responsibilities include the evaluation of current thinking, regulatory expectations, and related information to establish cleaning validation strategies, interfacing with Corporate QA, Engineering Tech Center to interpret and influence cleaning related standards, developing and ensuring delivery of cleaning validation training, and working across Manufacturing sites to consult/provide guidance on cleaning validation approaches and best practice documents, as needed.  The position will also foster strong alliance within customer/supplier groups to facilitate preparation for cleaning validation during development of new drug products/substances leading to first time success and reliable product supply. Additional responsibilities include consultation on cleaning validation study design and assistance in addressing broader issues/challenges.

Key Objectives/Deliverables/Responsibilities

• Provide support globally for drug product and API cleaning validation by consulting as requested. Provide one on one and group coaching. Consult on cleaning process challenges as needed, including scientific aspects of cleaning processes and control strategies (process and/or materials).
• Regularly disseminate and interpret cleaning validation related information and Lilly expectations including upcoming changes to Lilly requirements to Manufacturing sites/personnel executing cleaning validation work.
• Foster global Lilly collaboration, shared learning, and continuous improvement in efficiency, effectiveness/robustness, and compliance of cleaning processes and cleaning validation through the replication and application of science and risk-based approaches/tools or metrics. Promote integration of TS/MS with Development, Manufacturing/Quality, Engineering, or other functions towards this goal. Drive standardization and global philosophies/approached across Manufacturing sites, where appropriate.
• Develop and deliver/ensure delivery of training/education on cleaning validation and related cleaning topics across all Lilly manufacturing and packaging operations.
• Provide cleaning validation program assessments as requested. Support or consult with TS/MS Leaders, other Leaders or Global Quality auditors as requested to assess and ensure appropriate consistency in compliance to standards including use of metrics or other tools.
• Proactively monitor external trends or changes in cleaning validation expectations and thinking. As appropriate to Lilly concerns, influence external technical and regulatory/compliance philosophies in this area. Share current thinking, citation information and assist with translating new concepts/requirements into practical applications.
• Work with Quality, Toxicology and Patient Safety or other groups to provide TS/MS support and consultation in the development and application of cross contamination/Product Protection Control Strategies as related to cleaning.

Basic Requirements:

• Significant prior relevant experience & knowledge in manufacturing/packaging and cleaning validation of pharmaceuticals (7-10 years minimum).
• Excellent oral and written communication skills as well as strong interpersonal skills.
• Ability to work with or lead teams as well as working independently.
• Ability to critically evaluate issues, multi-task, plan and meet project due dates and be responsive to customer requests.
• Background should include practical application of cGMP's and familiarity with cleaning validation practices in multiple organizations. Experience in a role directly supporting manufacturing.
• Direct experience or ability to quickly learn and apply cleaning validation principles across drug substance, drug product and multiple manufacturing platforms/technologies.
• Knowledge of guidance and regulatory documents governing cleaning validation related standards.

Additional Preferences:

• Additional relevant industrial experience in any of the following associated pharmaceutical manufacturing platforms s Peptide/Oligonucleotide, Monoclonal Antibody, small molecules, cell banking, and ATMP Manufacturing.
• Experience providing sterilization validation related oversight of new and existing facilities including inspection readiness and preparation, root cause analysis, CAPA, and Quality Risk Management.
• Strong capability to influence personnel and management across the organization.
• Close interaction with quality to enable internal audits that identify risks.

Education Requirements:

Minimum requirements include a bachelor’s degree in pharmacy, science or engineering related field.

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 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

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.

#WeAreLilly