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: Leading a technical staff which perform activities related to cleaning, sterilization, filter and temperature mapping validation in support of parenteral manufacturing. First point of escalation in the event of floor issues and/or schedule changes. Provide guidance on time management, development opportunities, and priorities for direct reports to support operations. Key position responsibility, in addition to leading the team, is to address technical challenges, execute work to meet site/area deliverables, collaborate with cross functional team members to integrate validation activities in production schedules, ensure associated documentation adheres to Quality and regulatory standards and is approved within designated timelines. The position requires knowledge of cGMPs, equipment performance qualification/validation for sterilization, cleaning, temperature mapping and filtration, applicable global regulatory manufacturing guidance, and the corporate/industry standards for Parenteral manufacturing. Work with peer leadership in a positive fashion to deliver on technical objectives, specific business plan and quality objectives. 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. * Serve as first point of escalation for technical issues. * Responsible for planning, coordinating, and providing technical process support for issues that arise related to/impact Validation efforts. * Performance management and development of staff. * Partner within TS/MS Validation SMEs and across functional disciplines to influence and implement the validation agenda, site business plan objectives and GMP Quality Plan objectives. * Technical ownership, review and approval for technical protocols, summary reports, deviations, and change controls. * Responsible for ensuring technical documentation meets Quality and regulatory standards and are completed within designated timelines. * Coordinate with corresponding functional disciplines to schedule Validation activities and ensure compliance of schedules. * Responsible for managing area/site Validation initiatives/projects and personnel ensuring adherence to timelines and deliverables. Basic Requirements: * Bachelor's degree in scientific disciplines of Chemistry, Biology, Pharmacy, Engineering or a related field. * Minimum of 5 years of cGMP Pharmaceutical Manufacturing support experience. Additional Preferences: * Six Sigma Green Belt or Black Belt certification. * Teamwork and interpersonal skills. * Technical leadership, administrative and organizational skills. * Problem solving and independent decision-making skills. * Multi-tasking and communications skills. * Ability to influence diverse groups. * Computer and statistical analysis skills. Other Information: * Potential overtime to support off hour issue resolution. * Minimal travel required. * Applicant will work in various areas within the Parenteral Plant. Some allergens are present in the parenteral plant. Mobility requirements and exposure to allergens should be considered when applying for this position. This job specification is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job specification. As always, you should consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position. 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 $96,000 - $140,800 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