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.

　　The CSQA (Computer Systems Quality Assurance) consultant provides support to Parenteral Products production, while maintaining quality systems and GMP compliance. The CSQA Consultant provides primary support to Facility / Utilities / HVAC process teams and the IDS functional group, providing assistance and mentorship in non-conformance investigations, design, construction, equipment and computer systems, change control proposals, procedure revisions, GMP drawings, validations, and commissioning and qualification. The CSQA Consultant’s position is crucial for maintaining GMP compliance and in the preparation for pre-approval and general inspections by various regulatory agencies.

　　Responsibilities:

　　Responsible for maintaining a safe work environment, leading safety initiatives, and working safely and accountable for supporting all HSE Corporate and Site Goals

　　Support Utilities / HVAC process teams, as outlined in MSOE standard

　　Influence and lead all aspects of the Commissioning and Qualification (C&Q) and Computer Systems Validation (CSV) of GMP assets, including impact assessment of testing discrepancies

　　Influence and coordinate Maintenance / Calibration programs within Indy Parenteral, including benchmarking with other sites

　　Support process team projects and communicate impact to operational areas and associated support groups

　　Perform approvals for Critical Alarm Audits, Utilities Reports, and Business Reviews

　　Redline, review, and approve GMP documents / drawings

　　Perform audit trail review approvals and advise on data integrity concerns

　　Coach and mentor others in aspects of fundamental CSQA support, including process knowledge, problem solving, project management, and documentation design

　　Assist in self-led and / or agency inspections

　　Evaluate possible product quality impact for any GMP-related incident, perform initial leveling of non-conformances, and support the investigations

　　Basic Qualifications:

　　Bachelor of Science Degree in Automation Engineering, Computer Science, or equivalent experience (i.e., 5+ years of experience in Automation / IT or computer system validation)

　　Demonstrated experience in a GMP facility

　　Proficiency with IT systems development life cycle

　　Proficiency with Computer Systems Validation (CSV) and ability to right-size validation based upon risk

　　Technical proficiency with Microsoft Office, EDMS, SQL, TrackWise, SAP, etc.

　　Demonstrated strong communication and interpersonal interaction skills, and ability to influence others and collaborate

　　Additional Skills/Preferences:

　　Previous experience with Lilly deviation and change control process

　　Experience in Production, Automation Engineering, QC, QA, or IDS preferred

　　Knowledge of cGMP's

　　Demonstrated technical writing and written communication skills

　　Additional Information:

　　Overtime may be required.

　　May be required to support off shift activities related to operational issues

　　Applicant may work in various areas within the Parenteral Plant. Some allergens are present in the Parenteral Plant. Mobility requirements and exposure to allergens should be considered when applying for this position.

　　May be subject to Post Offer Exam

　　Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( [email protected] ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. 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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