Consultant - Validation

About the Tech@Lilly Organization : u00A0

Tech@Lilly builds and maintains capabilities using cutting edge technologies like most prominent tech companies. What differentiates Tech@Lilly is that we create new possibilities through tech to advance our purpose u2013 creating medicines that make life better for people around the world, like data driven drug discovery and connected clinical trials. We hire the best technology professionals from a variety of backgrounds, so they can bring an assortment of knowledge, skills, and diverse thinking to deliver innovative solutions in every area of the enterprise. u00A0

About the Business Function : u00A0 u00A0

The Tech@Lilly Digital Office (DO) and Global Services (GS) team leads digitalization across organizations spanning the enterprise with Finance, Legal, Ethics & Compliance, Corporate Affairs and Human Resources as well delivers best-in-class ERP Solutions.u202Fu202F This team leverages technology and analytics to enable transformations across the enterprise. u00A0

Job Title : Consultant - Validation u00A0

As a C onsultant - Validation , you will be responsible for executing IT system operational compliance activities following Lilly standards and processes . u00A0 u00A0

About the team : u00A0

Validation - Center of Excellence ( CoE ) is a specialized team that provides CSV services across all Tech@Lilly business functions. We adopt a modern, enterprise-wide approach that emphasizes automation and simplification, ensuring validation activities are consistent, effective, and aligned with industry best practices and regulations . u00A0

The DO / GS organization is actively looking for a motivated candidate . In this role, you will be responsible for driving IT quality & compliance, and assurance across Lillyu2019s mission-critical systems spanning across various business functions. u00A0

Do you have a passion for shaping the future of validation by embracing modern approaches like use of AI and Automation in validation If so, please apply. u00A0

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What youu2019ll be doing : u00A0 u00A0

Innovation & Automation : u00A0

Drive innovation in validation by exploring and leveraging AI, digital tools, and automation technologies to streamline validation documentation and operational compliance . u00A0 u00A0

Identify opportunities to simplify and automate IT system operational compliance activities through digital tools or AI-enabled solutions and adoption of risk-based approaches and automation frameworks . u00A0

Continuously evaluate emerging technologies (e.g., AI-assisted authoring, digital validation platforms) and recommend practical use cases for efficiency and quality improvement. u00A0

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Operational Compliance : u00A0

C oordinate IT system operational compliance activities and ensure compliance with regulatory requirements and Lilly processes . u00A0

Responsible for applying appropriate right sizing method / approach and determining the nature and content of d eliverables in scope. u00A0

Oversee AI / auto generated validation documents by reviewing and updating content s to ensure accuracy, compliance, and alignment with Lillyu2019s quality management system . u00A0

Escalate and communicate operational issues , critical compliance findings and risks to the Information System Quality (ISQ) organization and other key stakeholders of the system. u00A0 u00A0

Educate stakeholders (Owner, Custodian) on Lilly IT operational processes and compliance requirements . u00A0

Collaborate with cross-functional teams to identify and mitigate compliance risks, while providing guidance and training on best practices and regulatory requirements. u00A0

Change Management : u00A0

Ensures IT system change requests (CR) are executed in compliance with Local / global change control procedures. u00A0

Review CRs and e nsure the accuracy and completeness of all change requests. u00A0

Review the impacted validation deliverables.u00A0 u00A0

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CAPA Management : u00A0

Support IT system custodian and CAPA owners in CAPA implementation, Consultation and closure.u00A0 u00A0

Ensures IT CAPAs are implemented and closed on time. u00A0

Create / Review CAPAs and ensure the accuracy and completeness . u00A0

Access Roster , Privacy and Periodic Review : u00A0 u00A0

Facilitate and s upport the system custodian / owner and area management to execute access roster and periodic review followed by respective Corrective and Preventive Action ( CAPA ) closure . u00A0 u00A0

How You Will Succeed : u202F u00A0

Achieving measurable improvements in IT operational compliance (e.g., reduced review cycle time, timely CAPA completion ). u00A0

Contributing to continuous improvement for operational compliance processes . u00A0

Promoting simplification and harmonization across systems and geographies. u00A0

Driving CSA adoption to simplify and modernize CSV, focusing on risk-based assurance rather than excessive documentation. u00A0

What You should Bring : u00A0

In-depth knowledge of regulations, guidelines, and industry standards related to CSV, data integrity, and computerized systems like GxP , GAMP 5, FDA 21 CFR Part 820, 21 CFR 210, 21 CFR 211 , 21 CFR Part 11 , EU Annex 11 , ALCOA+ + Principles , etc . u00A0 u00A0

Hands-on expertise in preparing, reviewing, and approving validation deliverables. u00A0

Strong knowledge of IT system operational compliance processes, including Periodic Reviews and Access Roster Reviews. u00A0

Hands-on experience with commonly used industry tools (e.g., Jira, ServiceNow, Veeva). u00A0

Basic Qualifications and Experience Requirement : u00A0 u00A0

Bacheloru2019s degree in computer science, Information Technology, or a related field,u00A0 u00A0

Overall 5 + years of experience in CSV in pharmaceuticals or life sciences industry . u00A0 u00A0

Must have extensive knowledge of GxP , regulatory requirements, and IT system validation processes. u00A0

Demonstrated expertise in leading compliance initiatives and fostering cross-functional collaboration. u00A0

Strong experience in regulatory compliance, validation processes, risk assessment, IT systems change management, stakeholder collaboration, continuous improvement, project management, and analytical problem-solving. u00A0

Ability to collaborate with technical and non-technical team members . u00A0

Additional Skills / Preferences : u00A0

Excellent interpersonal , analytical, problem solving, and investigative skills . u00A0

Strong communication and collaboration skills. u00A0

Knowledge of Agile principles and frameworks (e.g., Scrum, SAFe ), including related tools (such as Jira) . u00A0

Additional Information : u00A0 u00A0

Availability to work flexible work hours is / may be required .u202FThis team will support continuous operations across two shifts and therefore, this role will require non-standard work hours, and some work on weekends and holidays.u202F Appropriate adjustments in benefits will be provided for employees working non-standard hours where applicable. u00A0

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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 () 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.

Lillyu00A0does 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.

#WeAreLilly

Skills Required

Servicenow, 21 Cfr Part 11, Automation, Veeva, Csv, Ai, Jira, Gxp