Engineer-Quality Assurance

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.

Responsibilities:
Facilitate and drive compliance with Good Manufacturing Practices and corporate quality policies in the PR01 plant, as applied to the areas of utilities, equipment, computerized systems and facilities in oral solids manufacturing plant.

• Participate in the definition of strategies, reviews and approvals of the qualification and validation protocols of facilities, utilities, computerized systems, if applicable, and equipment in the PR01 plant.
• Evaluate and approve the impact of proposed changes in light of validated processes, applicable regulations, and regulatory commitment.
• Evaluate the impact of deviations regarding validated processes and applicable regulations to ensure product attributes are not affected. Ensure the effectiveness of the associated CAPA.
• Ensure that periodic evaluations defined in local procedures are carried out within the established frequencies. Ensure the proper identification of any trend and the generation and implementation of the corresponding action plans.
• Ensure that adequate procedures are available to cover all activities related to GMPs and regulations applicable to facilities, utilities and equipment.
• Manage the Self-Inspection (SI) Program for your areas of responsibility (i.e., regulatory plans, etc.). Ensure that action plans are generated and implemented for any identified deficiencies.
• Ensure compliance with record retention and proper record maintenance requirements for documentation related to the design, qualification, and maintenance of facilities, utilities, computer systems, and equipment.

• Ensure that Quality Systems are kept up to date by promoting a regulatory environment through specialized forums that assist in the investigation and closure of regulatory documents.
• Monitor compliance with the pest control program, ensure compliance with the requirements of construction activities and routine monitoring of facilities.
• Actively participate in the evaluation and approval of validations, qualifications, deviations and change proposals related to the utilities systems, equipment systems and facilities used in manufacturing processes. Evaluate and approve preventive maintenance procedures (job plans), work orders, as required, and corrective maintenance.
• Ensure compliance with Data Integrity requirements under 21 CFR Part 11. Ensure compliance with computerized system validation policies and guidelines for applications used in GMP activities and automation technology.

• Bachelor's degree in engineering (Mechanical, Electrical preferred)
• Minimum 2 years of experience in Pharmaceutical GMP environment
• Experience in facilities, utilities and equipment, statistical sampling systems, quality systems, FDA regulations
• Professional License of Engineer (PE) or Engineer in Training (EIT)

Job title and salary commensurate with experience

Additional Skills/Preferences:

• Bilingual (English and Spanish)
• Ability to establish positive interpersonal relationships and interact with people
• Ability to multi-task and work on multiple projects at once
• Exercising good judgment and decision-making
• Work under minimal supervision
• Knowledgeable in GMPs, GDPs, Safety (OSHA), Computerized System
• Strong technical writing abilities
• Strong compliance mindset

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, 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 help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

#WeAreLilly