Engineer - Quality - Global CSQA

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.

Organization Overview:

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

The Engineer - Quality - Global Computer Systems Quality Assurance (CSQA) role is responsible for ensuring that their assigned functional areas, projects and/or systems comply with corporate computer system validation (CSV) standards. This includes providing consultation and interpretation of Corporate Computer Systems Standards, Practices, and Procedures, providing oversight for CSV execution (including approving CSV documents per corporate standards/practices), maintaining awareness of corporate and external standards as they relate to CSV, and assurance of inspection readiness within supported areas.

While the primary area of responsibility for this position will be as aligned with Information Systems Quality (ISQ) needs, it is intended to include a significant portfolio within the Manufacturing and Quality organization. As such, preference will be given to candidates who can demonstrate strength, technical knowledge and proficiency in those subject matter areas (e.g., manufacturing execution systems, laboratory information management systems, quality systems, etc.).

Key Objectives/Deliverables:

Maintain Inspectional Readiness:

• Ensure supported systems are validated in compliance with applicable standards and procedures
• Ensure all quality actions and commitments for supported areas are appropriately tracked
• Participate in self-inspections, audits, and supplier assessment activities to ensure the state of computer system validation is clearly and accurately understood
• Ensure all Inspection Readiness materials are current and appropriate
• Provide periodic updates to key stakeholders
• Escalate issues appropriately

Deliver Projects, Programs, and Support:

• Provide consultation and interpretation on policies and procedures as related to the supported computer system
• Provide training to customer areas on CSV-related topics as needed
• Partner with Business, Business Quality, and IT customer areas to deliver business value
• Understand customer, company, and Quality priorities
• Review/approve documents per CSV expectations within agreed service levels, or clearly communicate when activities will be completed
• Engage customers and Quality Assurance management in appropriate discussions of risk management
• Ensure suppliers of computer systems or services meet quality expectations
• Escalate computer system quality issues to the appropriate persons
• Strive for and promote consistency within the CSQA organization

Streamline and Continuously Improve:

• Eliminate non-value-added activities in order to focus on activities which continuously improve assurance of quality. This may include engagement in process improvement projects.
• Identify opportunities for streamlining and simplification and assist in developing improved solutions
• Understand external trends and potential ramifications for the supported IT area(s)

Grow Capabilities and Knowledge:

• Share lessons learned and best practices with others
• Support teammates by sharing experience, providing backup coverage, consulting and assistance

Minimum Requirements:

• Bachelor’s degree in a technology-related field such as Computer Science;
• 5+ years’ experience in IT, Automation, or computer system validation

Additional Preferences:

• Understanding of process development and/or improvement (e.g. Six Sigma)
• Experience conducting risk assessments, self-inspections, audits and/or supplier assessments
• Demonstrated ability to communicate with customers, including good oral and written communication skills and presentation skills
• Demonstrated influence, mentoring skills with peers and management
• Proficiency with IT systems development life cycle
• Proficiency with Microsoft Office products
• Experience with Computer Systems Validation
• Prior IT system development experience or QA experience
• Competency in IT technical disciplines (e.g. Information Security, Programming, Data Analytics, Cloud
• Knowledge of IT Best Practices (e.g., COBIT, LSEF, ITIL, GAMP)
• IT-control related certifications (e.g., CISA, ISO, ITIL, CSQE (ASQ, QAI))

Other Information:

• QA Representative must successfully complete the Eli Lilly CSQA…