QA Engineer, Foundry

Overview

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 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 put people first and are looking for people who are determined to make life better for others.

Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. The first-ever facility of its kind, the Foundry will combine research and manufacturing in a single location to optimize manufacturing processes, increase capacity for clinical trial medicines, and reduce costs and environmental impact.

Responsibilities

• The Foundry QA Engineer provides technical guidance and leadership in interactions with business and operations personnel.
• Provide consultation and interpretation of local procedures, corporate standards, and regulatory expectations.
• Review and approve applicable procedures to ensure compliance with corporate standards and regulatory requirements.
• Assess gaps between local procedures and corporate standards and facilitate remediation efforts.
• Influence and oversee Commissioning and Qualification (C&Q) and Computer Systems Validation (CSV) of GMP assets, including review and approval of deliverables (protocols, drawings, test documents, etc.).
• Influence and oversee Maintenance / Calibration programs within the Foundry, including benchmarking with other Lilly sites.
• Evaluate potential product quality impact for GMP-related incidents (deviation or change control), perform initial assessment, and support investigations to ensure proper root cause analysis (RCA) and CAPA.
• Escalate and / or notify management for departures of critical nature and ensure issues are addressed appropriately.
• Ensure the Foundry is audit ready at all times and participate in internal / external inspections.

Basic Requirements

Additional Preferences

Other Information

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.

WeAreLilly

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce. If you require accommodation to submit a resume, please complete the accommodation request form. 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 $63,000 - $162,800. Full-time employees are eligible for a company bonus (dependent on company and individual performance). Lilly offers a comprehensive benefit program, including eligibility for medical, dental, vision, and prescription drug benefits; 401(k) participation; pension; vacation benefits; flexible benefits; life insurance; time off and leave; and well-being programs.

WeAreLilly

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