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.

Main Purpose and Objectives:

To provide technical guidance, compliance expertise and leadership with regards to the quality standards to maintain and improve site operations; to define, design, implement, qualify and start-up assets (equipment/facilities) and utilities/processes; quality systems and Good Manufacturing Practices (GMP) compliance.

The Principal Associate position is essential for maintaining Good Manufacturing Practices (GMP) compliance, quality systems, training other personnel in the department, maintain external linkages and support preparation for Pre-Approval and General Inspections by various regulatory agencies.

General Responsibilities:

Serve as a key resource for initiatives/projects related to assets (equipment/facilities), utilities and processes to ensure deliverables are achieved in compliance.Support floor operations: review/approve procedures, troubleshooting and issues resolution.Participate in and/or lead self-inspection activities.Monitor the qualified utilities performance to ensure compliance with Quality (internal/external) requirements/regulations.Represent the Supervision in meetings as required.Know the Operational Control Strategy and potential failure modes of the operation.Perform leveling, review and approval of changes.Use statistical data to understand the sources of variability and to continuously improve.Serve as a liaison between supported area, engineering, maintenance and utilities and other Quality areas (Laboratories, Incoming, etc.).Perform leveling and review event investigations and complaints, assuring robustness of Root Cause Analysis and effectiveness of Corrective Action and Preventive Actions (CAPA’s).Have a comprehensive knowledge of the science behind the process, engineering first principles and equipment to facilitate science-based decision making.Support maintenance, engineering, and qualification strategies and drive improvements.Review and approve qualification and maintenance documentation.Ensure documentation is issued using good technical writing.Notify senior management of significant quality related issues.Maintain, improve, and serve as a subject matter expert on Facilities Utilities Maintenance and Engineering (FUME) Quality Systems.Provide coaching and guidance on quality expertise as related to utilities, equipment, maintenance, and facilities to supported areas.Coach Quality Assurance (QA) Engineers in technical and compliance aspects.Educate others on current Good Manufacturing Practices (cGMP) and Facilities Utilities Maintenance and Engineering (FUME) external/ Global Quality Standards (GQS) requirements.

Other Job Requirements:

Ability to:

Establish positive interpersonal relationships and effectively interact with people and departments internally and externally.Organize and prioritize multi-functional tasks.Work under time and schedule pressure.Exercise good judgment and be assertive when required.Work under minimal supervision.Excellent decision-making.Strong customer service focusStrong compliance mindset and sound judgement

Availability to:

Travel within and outside Puerto Rico and the Unites States.Work as a resource in other areas of the business, based on business needs.Provide support to a 24/7 operation when required, (irregular hours, shifts rotation, weekends, holidays, emergencies.

Educational Requirements:

Bachelor’s Degree in Chemical Engineering, Biotechnical Engineering, Biomedical Engineering, Mechanical Engineering, or related field.

Experience Requirements:

At least five (5) years of experience as Quality Engineer (preferred). At least five (5) years of experience in automated bulk pharmaceutical GMP operations (Production, Engineering, QA or Technical Services) with thorough understanding of facilities, utilities and maintenance, commissioning and qualification and understanding of Quality Systems.

Important Notice: In order to maintain the excellent reputation of our company, the quality of our products, and the safety of our working environment, the company will take all reasonable measures to ensure that drug abuse by employees or other persons does not jeopardize the safety of our operations or the quality of our products or adversely affect in any way the company or its employees. The company recognizes that drug use both on and off the job can be detrimental to the company and its efforts to provide a drug-free workplace. Even if prescribed under a state medical marijuana law, marijuana remains illegal under federal law. Marijuana is considered unauthorized by Lilly.

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

$51,000 - $148,500

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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