Computer System Validation Csv Jobs in Indiana (NOW HIRING)

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Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development in Lebanon, IN. The first-ever facility of its kind, combining research and manufacturing in a single location, the Medicine Foundry will allow Lilly to further develop innovative solutions to optimize manufacturing processes and increase capacity for clinical trial medicines, while also reducing costs and environmental impact.

What You'll Be Doing:

As an Informatics Engineer, you will partner with the Process Translation and Analytical Laboratories functional areas and site, group, and global IT teams to implement and support digital laboratory solutions that enable the Foundry's operational objectives. Your scope includes key lab systems such as Laboratory Information Management Systems (LIMS), Laboratory Execution Systems (LES), Electronic Lab Notebooks (ELN), Chromatography Data Systems (CDS), and Environmental Monitoring (EM) platforms.

You will be driving and supporting system design, configuration, validation, and release - serving as an IT domain expert (SME) for analytical laboratory IT systems at the Foundry.

How You'll Succeed:

System Implementation & Configuration

• Lead system design and configuration sessions with analytical lab SMEs for LIMS, LES, ELN, and CDS platforms, translating business and scientific processes into validated technical solutions.

• Develop and implement Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols in compliance with 21 CFR Part 11 and EU Annex 11.

• Lead data integrity requirements across lab systems and ensure audit readiness for regulatory inspections.

• Coordinate instrument integration and data flows between lab equipment and LIMS/LES platforms.

• Support site deployment and upgrade of analytical laboratory IT systems throughout the facility's startup and operational phases.

Validation & Compliance

• Produce and maintain Computer System Validation (CSV) documentation, standard operating procedures (SOPs), and validation plans in alignment with applicable regulatory frameworks.

• Ensure systems remain in a validated state and lead their lifecycle through releases, recapitalization, and retirement.

• Build and maintain awareness of regulatory, legal, and quality requirements impacting the quality control laboratory, ensuring solution requirements comply.

Collaboration & Readiness

• Collaborate with site and global IT system teams to ensure operational readiness of laboratory systems supporting the Foundry's release objectives.

• Act as a key IT SME for analytical laboratory IT systems, organizing and educating peers on system use and best practices.

• Support audits and provide oversight for management reviews, laboratory metrics, equipment records, and laboratory documentation.

Your Basic Qualifications:

• Bachelor of Science degree in IT, Chemistry, Pharmacy, Science, Engineering, or related field.

• 1+year of relevant experience in information technology, engineering, computer system validation, quality control support, or a related area.

• Experience with Computer System Validation (CSV) methodology.

• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

Additional Skills / Preferences:

• Strong working knowledge of analytical laboratory IT systems including:

• LIMS: LabVantage, LabWare

• ELN: Benchling, Signals Notebook, or equivalent

• CDS: Empower, or equivalent

• LES/MES: L7, MODA, or equivalent

• Solid knowledge of CSV process and electronic records/electronic signatures (ERES) requirements.

• Experience working in a GMP-regulated environment (pharmaceutical, biotech, or equivalent).

• Demonstrated ability to prepare and implement IQ/OQ/PQ protocols and associated documentation.

• Experience with API/middleware integration and instrument connectivity between lab equipment and informatics platforms.

• Understanding of data integrity frameworks applicable to GMP lab environments.

• Familiarity with Agile or iterative delivery methodologies in a regulated setting.

• Demonstrated learning agility and curiosity; ability to analyze, anticipate, and resolve complex issues through sound problem-solving.

• Ability to accurately translate business and scientific processes into IT requirements and solutions.

• Effective communicator across diverse forums and audiences, including technical peers, QA, and business customers.

• Certification in relevant IT areas (e.g., ITIL, cloud, AI) is a plus.

Location & Work Flexibility
This role will initially be located out of Indianapolis, IN. Once constructed the permanent location will be based at our new Lilly Medicine Foundry in nearby Lebanon, IN.

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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.

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Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women's Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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