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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.

Position Brand Description:

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 38,000 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 individuals who are determined to make life better for people around the world.

Lilly is entering an exciting period of growth and we are committed to delivering innovative medicines to patients around the world. Lilly is investing over $3 Billion to create a new state-of-the-art manufacturing site for Drug Substance, in Lebanon, Indiana. The brand-new facility will utilize a variety of Platforms and have the latest technology for API Manufacturing and Technology. This is an exciting once-in-a-lifetime opportunity to help build and operate a new site. The Lilly Lebanon API Manufacturing site will be built using the latest high-tech equipment, advanced highly integrated and automated manufacturing systems, and have a focus on minimizing the impact to our environment. This is an opportunity you don’t want to miss!

What You’ll Be Doing :

This role will provide CSV technical leadership across the different IT groups in Lilly Lebanon focused on external regulations, industry best practices, policies and procedures governing the process to validate, maintain and retire new and existing computer systems. The position will be responsible for defining and maintaining CSV local policies and procedures to ensure that all solutions deployed are developed and implemented according to enterprise policies and regulatory requirements.

This role will collaborate within the Lilly Tech at Lilly and Quality organizations and externally with industry forums and standard to ensure the state of compliance of computer systems.

Responsibilities:

• Oversight and support of computer systems validation activities, including the review and approval of all documentation issued to support the validation/qualification of non-GMP and GMP systems, as appropriate

• Provide input and execute the risk management approach for CSV for the Lilly Lebanon sites.

• Acts as the primary contact and has principal responsibility for supporting all internal and external CSV related audits and privacy related inspections, working in collaboration with Computer Systems Quality Assurance on GMP related systems. Also responsible for privacy initiatives to ensure that all computer-based systems comply with internal and external privacy policies and requirements

• Support Data Integrity readiness for regulatory authority inspections at the Lilly Lebanon site and if required, effectively represent the company during regulatory audits through interaction/ discussion with regulatory officials related to data management and integrity.

• Anticipate short term and future needs of the function to focus. Enable and influence business effectiveness by identifying opportunities for leveraging technology

• Maintain the organization's System Development Life Cycle (SDLC) ensuring that current business and regulatory requirements are satisfied. Establish a framework to monitor and audit adherence to SDLC.

• Collect, evaluate and prioritize opportunities to improve compliance, privacy, and SDLC related policies and procedures. Report, analyze, audit and develop plans and programs to support continuous quality improvement.

• Participate in business plan activities and in appropriate site governance and steering teams.

• Help determine the GMP designation and testing requirements for analytics tools.

• Must have working understanding of compatibility, integration, interoperability, stability, scalability and usability of products/services being implemented to ensure validation activities cover all requirements

• Must ensure security and privacy risks are considered in the design and testing of IT systems 

Basic Qualifications:

• Bachelor’s Degree in relevant fields such as Information Systems, Computer Science or Programming; or BS Engineering (Computer, Electrical, Industrial, Mechanical, Chemical) or equivalent

Additional Preferences:

• Experience working in a regulated industry (i.e. GMP) and strong understanding of quality processes in IT applying to manufacturing and distribution

• Ability to communicate effectively in written and verbal form (in English), with proven success at delivering key messages to both management and peers across multiple business functions

• Demonstrated ability to write technical documents, develop business presentations and effectively communicate concepts to a wide range of personnel including senior leadership

• Strong collaboration with colleagues at all levels

• Demonstrated courage & integrity

• Demonstrated success in influencing without authority

• Ability to take initiative, to be assertive, to lead by example and to build high-quality relationships

• Highly flexible, adapting to changes in priorities, requirements and processes is required.

• Demonstrated proficiency in planning and the ability to carry out tasks with a high degree of independence as well as being able to work in a team environment

• Demonstrated ability to interpret and apply standards to different situations by understanding site needs and applying good problem-solving skills

• Strong knowledge and technical expertise in areas of cGMPs, processes, production practices, and quality systems

• Recognized understanding of regulations governing CSV and data integrity

• Speak up with ideas as well as concerns and ensure the psychological safety of others.

• Demonstrated learning agility and ability to think creatively; try new ideas and apply learnings.

• Business acumen, and the ability to communicate to executives, business domain stakeholders and technical staff alike

• Experience with innovation and ideation methods, such as design thinking.

• System integration experience, including interface design, and familiarity with web-oriented architecture techniques

• Understanding of common information architecture frameworks and information model

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 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.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

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