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.

• Are you ready to ensure the highest standards of quality and compliance in pharmaceutical manufacturing?

We are seeking a QA Associate:

• Engineering & Computer System Validation to join our Manufacturing Team.

This is an opportunity to play a critical role in maintaining GMP compliance for automation systems and supporting the validation lifecycle of computer systems that directly impact product quality. Your expertise will help ensure that our engineering and IT infrastructure meets the rigorous standards required to deliver safe, effective medicines to patients worldwide.

Role Objectives

• Ensure that Validation and Qualification activities for Automation Systems are fully compliant with GMP standards and internal quality requirements.
• Provide Quality oversight for Computer Systems and Engineering/Utilities functions.
• Support cross-functional teams in investigating and resolving non-conformances related to Computer Systems and Engineering.
• Contribute to root cause analysis and problem-solving efforts to address maintenance and computer system failures.
• Collaborate on the planning and execution of maintenance and IT activities during plant shutdowns and return-to-service operations.

Main Responsibilities

• Review and approve maintenance programs and validation deliverables to ensure alignment with quality standards.
• Provide Quality oversight for Engineering team activities, ensuring compliance with regulatory requirements.
• Participate in deviation investigations related to computer systems and maintenance operations.
• Conduct gap analyses to verify departmental activities meet quality and compliance requirements.
• Support the definition and coordination of shutdown and return-to-service activities involving maintenance and IT functions.
• Collaborate with cross-functional teams to implement corrective and preventive actions arising from non-conformance investigations.
• Maintain up-to-date knowledge of regulatory expectations and industry best practices for computer system validation

Required Qualifications

• Master's Degree in a scientific discipline (Engineering or Chemistry preferred).
• Good knowledge of English (B2/C1 level).
• Familiarity with manufacturing computer systems and their validation requirements.
• Understanding of production processes and quality environment in a regulated setting.
• Previous experience in manufacturing activities, preferably in a pharmaceutical or GMP-regulated environment.

Preferred Qualifications

• CSQA (Certified Software Quality Analyst) certification or equivalent.
• Strong teamwork orientation and ability to collaborate across functions.
• Excellent organizational and interpersonal skills.
• Experience with deviation management and root cause analysis methodologies.

What We Offer

Step into a role where your expertise is recognized, appreciated, and rewarded. As a member of our team, you can expect:

• Competitive Salary: We offer a competitive base salary supplemented by an annual variable component based on achieving objectives.
• Relocation Package: You will be eligible for a relocation package based on your location.
• Comprehensive Benefits: Enjoy a well-rounded welfare package, including an extensive insurance plan.
• Annual Salary Review: We recognize and reward your continued effort with an annual salary review, providing opportunities for advancement based on your performance. As part of our commitment to your future, you may also be eligible to receive a stock option package, aligning your success with the company's growth.

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 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.

#We Are Lilly