QC Instrumentation Engineer

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:

Lilly is designing and building a Next Generation Biotech Drug Substance Manufacturing Facility in Limerick, Ireland. This is an exciting opportunity to help build and operate a state-of-the-art manufacturing site from the ground up. Our new Limerick facility will be one of Lilly’s most technically advanced manufacturing sites and will include next-gen manufacturing technologies, and advanced data collection and analysis platforms that will result in safety and quality improvements, increased productivity, and variability reduction.

We are seeking a QC Instrumentation Engineer to provide equipment lifecycle management support to the Lilly Limerick QC Laboratories. Main support functions include specifying and purchasing equipment; authoring equipment qualification packages, managing the equipment qualification process, and providing daily operational support of laboratory equipment by ensuring the equipment is maintained in a qualified state of compliance. The position requires an understanding of corporate quality systems, a detail-oriented quality mindset with an understanding of analytical/micro laboratory equipment, knowledge of lab methods to understand intended use of equipment and their failure modes effects. High-quality skills to include equipment troubleshooting, ability to prioritize, written and oral communication, decision making, interpersonal/people, computer applications, and problem solving.

Key Responsibilities:

• Author, execute, and review equipment qualification/validation protocols and strategies for the QC Laboratories.
• Support equipment lifecycle management and laboratory informatics initiatives.
• Support equipment connectivity activities, integrating QC instrumentation with LIMS and e-Systems to achieve a paper-less laboratory.
• Participate/lead in data integrity controls and improvement initiatives.
• Communicate with other functions and external vendors regarding qualification issues and key operational objectives.
• Act as liaison between the maintenance team and lab personnel to schedule preventative and corrective maintenance of equipment.
• Responsible for coordination of laboratory CSV activities, system upgrades, and data integrity.
• Apply knowledge of quality principles, GMPs, federal regulations, corporate standards and practices and local procedures in the development of qualification/validation protocols and equipment lifecycle management.
• Interact effectively with customers, support groups and development.
• Network with other areas to understand best practices, share knowledge, participate in global meetings and web seminars, and to ensure customer needs are met.

• Influence improvements and streamline quality systems relating to equipment. • Serve as equipment expert and technical resource in the review of technical documents.

Basic Requirements:

• Bachelor’s degree (Hons) in an engineering related field (Mechanical Engineering, Biomedical Engineering, etc.)
• 2 or more years of equipment experience with emphasis on GMP instrumentation.

Additional Preferences:

• Experience supporting analytical equipment in a GMP environment.
• Previous experience with managing data integrity regulations and controls
• Working knowledge of CMMS, Kneat, Empower, TrackWise, LabVantage LIMS, Veeva
• Working effectively with a cross functional group.
• Excellent written and oral communication skills and ability to collaborate and interact with management, scientists, engineering and IT personnel.
• Understanding of compliance requirements and regulatory expectations for GMP systems.

Additional Information:

Candidates must be able to travel for familiarization and training as required.

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.

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