System Engineer - Systems

Manufacturing And Quality Tech

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 and Role Overview

Lilly is entering an exciting and outstanding period of growth. The Manufacturing and Quality (MQ) Tech at Lilly organization is engaged in an exciting phase of transformation as we drive our Digital Plant vision across Lilly manufacturing at the same time supporting unprecedented growth in Lilly's manufacturing operation across the world.

This position develops, deploys, and supports laboratory and/or manufacturing systems to meet business and regulatory needs. This position requires business area knowledge and computer expertise to provide in-depth support (maintenance, updates and troubleshooting) for new and existing laboratory and/or manufacturing applications and computerized systems. This position will be responsible for the maintenance, updates and troubleshooting of Quality Management Systems (ie Nugenesis, SoftMax Pro, Tulip, Empower, LabVantage) and their related items. Additionally, this position will assist with site projects such as system updates and/or enhancements. This individual will solve computerized system issues, analyze information, implement new systems, and maintain and enhance existing solutions in accordance with corporate standards and guidelines. This role will collaborate with global IDS teams to meet goals for both current and anticipated future needs for new and existing technologies, practices and initiatives.

Responsibilities

• Create, modify, and enhance applications and systems to satisfy business information demands. Facilitate changes by delivering feedback from customers to application teams and communicate any changes applied ensuring operational procedures stay current and relevant.
• Assure adherence of applicable regulatory (i.e. cGXP, CFR, etc.) practices during execution of all work activities. Participate in audits, inspections, and associated readiness activities.
• Oversee and participate in the installation, configuration, and validation of lab systems applications. Develop and execute project plans, ensuring timely and quality delivery of solutions. Manage system customizations, scripts, and user interface enhancements.
• Proven ability to translate and lead complex lab/manufacturing requirements,
• Design and implement integrations between lab/manufacturing systems and third-party systems (ie Tulip), including standalone instruments and databases.
• Responsible for daily support of end users, and provide end user training
• Perform the pre-validation assessment of all computerized laboratory and/or manufacturing systems, ensuring that all validation requirements have been met prior to system testing.
• Enable data-driven decision making in pharmaceutical Quality Control and Manufacturing by developing and deploying interactive, easy-to-use dashboards and reports that support self-service analytics, ensure secure and compliant access to critical data, and provide real-time insights to enhance process efficiency, product quality, and regulatory compliance.
• Ensure that the technology solutions being implemented are compliant with all relevant regulations (i.e. 21 CFR Part 11, Sarbanes Oxley, GxP, privacy data practices, local and corporate policies).
• Provide IDS technical and/or validation direction related to computer system Change Management initiatives, as well as the selection, implementation, and upgrade of computerized systems. Support validation processes, including IQ/OQ/PQ documentation and audits.
• Identify, recommend, and implement automated solutions to address QC laboratory or manufacturing operations. Execute with precision, speed, and simplicity, ensuring compliance with Computer Systems Validation policies, standards, procedures, and practices. Train and assist business users in proper use of applications and computerized systems.
• Foster professional and inclusive behavior, invite new ideas and differing perspectives among team members, assuring an on-going positive relationship with the customers and other members of the IDS organization. Inspire and recognize teamwork.
• Serve as a liaison between local and corporate systems groups, cross-functional or cross-site teams, as requested, interfacing with system owners, IDS, QC, QA, Manufacturing, Automation, vendors, and other relevant functional areas. Build enterprise and cross-site connections to ensure integration and results.
• Ensure compliance to corporate and site policies and procedures to be audit ready, mitigate risk, and follow quality management practices. Support and abide by applicable Lilly policies as indicated in the Lilly Red Book and other company policies and procedures. All corporate compliance training requirements must be met as required and defined.

What You Should Bring

• Experience and knowledge of change management principles, methodologies, and tools.
• Exceptional communication skills – both written and verbal.
• Experience with large-scale organizational change efforts.
• Extensive experience leading change, communication and training efforts for multiple global, complex technology implementations.
• Stay active and current in business technology trends, direction and innovation related to business process and technology areas of focus by participating in external forums, conferences, and other venues as necessary.
• Desire to establish and maintain relationships with all levels across the company and external partners.
• Experience in health care, pharma, manufacturing or life sciences is a plus.
• Flexible and adaptable; able to work in ambiguous situations.

Basic Requirements

• BS/BA in Computer Science or related field required (or equivalent work experience).
• 5+ years IT or equivalent relevant experience.
• Minimum of 2+ years in the Life Sciences industry.
• Must maintain excellent working knowledge of pharmaceutical regulations (e.g. cGMP's, 21 CFR Part 11, Computers Systems FDA) and other applicable regulations (e.g. Privacy, OSHA, etc.) related to laboratory and/or manufacturing environment and system applications.
• 3+ years basic understanding of databases (Oracle, SQL, etc.) & hands-on experience in .NET, SQL, ASP.Net, Web Apps and related technologies and operating systems (Windows, etc.).

Additional Skills/Preferences

• MS/MBA desirable.
• Previous experience in a regulated environment preferred.
• Effective problem-solving and analytical skills to resolve operational problems.
• Excellent written and verbal communication skills with the ability to develop and present both business and technical presentations.
• Ability to build relationships across dimensions of difference, ask questions and invite others to contribute.
• Experience with managing external (vendor, consultant) business partners.
• Demonstrated business acumen.
• Speak up with ideas, concerns and to ensure safety of others.
• Demonstrated learning agility, and ability to think creatively, try new ideas and apply learnings.
• Highly motivated, enthusiastic to learn and share ideas and solutions effectively with management and colleagues.
• Collaboration with colleagues at all levels.
• Ability to work on multiple concurrent project initiatives.
• Demonstrate courage and integrity.
• Demonstrated success in influencing without authority.
• Strong customer service and teamwork oriented.
• Ability to take initiative, to be outspoken, to lead by example and to build high-quality relationships.
• Highly flexible, adapting to changes in priorities, requirements and processes is required.
• Working knowledge in the following systems is a plus: laboratory information management system (LIMS), LabVantage, NuGenesis, and additional laboratory standalone analytical systems.
• Hands on professional experience in BI development using Power BI or Tableau.

Additional Information

• Travel: 0-10%
• May be required to be on call.
• 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.

This job specification is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job specification. As always, you should consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position.

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