Sr. Principal Engineer - QA

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.

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 35,000 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:

The primary responsibilities of the Quality Engineer are to assure compliance with corporate quality systems and current GMPs for the Operations of

Indianapolis Device & Assembly Packaging (IDAP) site. This position provides quality oversight of the Production Quality System in support of operations, including assistance and mentorship in the execution of change controls, equipment qualification, process validation, computer system quality, deviations, and complaint investigations. This assignment will involve a high level of engagement with Operations, Engineering, and area Leadership.

• Promote safety awareness
• Remain current with individual training plan
• Observe, promote, and follow requirements related to safety, quality, security, customer service, and GMPs
• Provide consultation and interpretation of quality guidance documents regarding qualification / validation, cleaning, change control, production practices, deviations, CSQ, and complaint management
• Provide quality oversight and provide quality support for bringing new products into IDAP
• Provide quality oversight of the IDAP operations and processes to support QA Floor Reps / QA Technicians floor decisions
• Raise notification to management for departures of critical nature and assure issues are addressed
• Assess gaps between local and corporate standards and facilitate remediation efforts actively working with support areas
• Ensure area is always audit ready
• Support project timelines assuring compliance with Quality expectations
• Proactively work with areas to provide support and promote consistency with Quality expectations and discuss resolution with process team members
• Possess a detailed understanding of the IDAP processes including critical parameters, components used, equipment, etc.
• Actively assist in continuous improvements and efficiency projects
• Provide quality impact assessments, reviews and approvals on validation protocols, qualification documents, change controls, deviations, holds, procedures, and maintenance work orders related to the IDAP processes
• Actively seek expanded knowledge of applicable technologies, processes, and regulations through training, networking, floor presence, and project participation
• Provide leadership in communicating cGMP requirements to shop floor and promote best practices through direct contact with production, maintenance, engineering, and automation

Basic Qualifications:

• Bachelor's Degree in STEM

Additional Skills/Preferences:

• 3 or more years' experience in a GMP environment preferred
• Previous experience in Quality Assurance or Engineering preferred
• Knowledge of cGMPs, Production Processes, Quality Systems, and FDA regulations
• Experience supporting computer systems (e.g. CSV, CSQ, IDS experience)
• Proficiency with computer systems such as TrackWise, SAP, PMX, and Quality Docs
• Experience in conducting root cause investigations, and execution of change management, equipment qualification, and process validation
• Ability to communicate effectively with customers to carry out requirements
• Ability to work under time pressure, exert good judgment in special situations, make decisions independently under minimum supervision, and problem solve
• Ability to influence team interactions and lead initiatives
• Demonstrated strong oral and written communication and interpersonal skills
• Demonstrated decision making and problem-solving skills
• Demonstrated knowledge and understanding of manufacturing process and Quality Systems
• Demonstrated attention to detail<