Sr. Consultant - Validation

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.

About The Tech@Lilly Organization:

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 – 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. 

About The Business Function:

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.   This team leverages technology and analytics to enable transformations across the enterprise. 

Job Title: Senior Consultant - Validation 

As a Senior Consultant - Validation, you will be responsible for driving Computer System Validation (CSV)/Computer Software Assurance (CSA) activities, ensuring compliance, quality, and efficiency across Lilly computer systems following Lilly standards and processes. 

You also will be responsible to drive innovation by leveraging AI, digital tools, and automation to simplify and automate CSV processes. 

About The Team:

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.  

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 Lilly’s mission-critical systems spanning across various business functions. 

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. 

What You’Ll Be Doing:

Innovation & Automation:

• Drive innovation in validation by exploring and leveraging AI, digital tools, and automation technologies to streamline validation documentation, authoring, and review processes.  
• Identify opportunities to simplify CSV/CSA activities through adoption of risk-based approaches, automation frameworks, and smart documentation solutions, reducing effort while maintaining compliance. 
• Continuously evaluate emerging technologies (e.g., AI-assisted authoring, digital validation platforms) and recommend practical use cases for efficiency and quality improvement. 
• Identify and drive continuous improvement, automation, and simplification opportunities in validation processes using digital tools or AI-enabled solutions. 

Project Validation:

• Lead and coordinate IT system validation by managing the computer system lifecycle from validation/test planning to reporting and ensure compliance with regulatory requirements, Lilly processes and validation standards. 
• Responsible for applying appropriate right sizing method/approach and determining the nature and content of deliverables in scope. 
• Oversee AI/auto generated validation documents by reviewing and updating contents to ensure accuracy, compliance, and alignment with Lilly’s quality management system. 
• Review all the project validation deliverables authored by the project team (developer, SME etc.).  
• Escalate and communicate operational issues, critical compliance findings and risks to the Information System Quality (ISQ) organization and other key stakeholders of the system.  
• Educate project team members on Lilly IT processes and methodologies. 
• Collaborate with cross-functional teams to identify and mitigate compliance risks, while providing guidance and training on best practices and regulatory requirements. 
• Advise project team on implementation of compliance and security control requirements at the appropriate stages of system development. 
• Contribute to internal and external audits, assessments or inspections. 
• Ensures IT system change requests (CR) are executed in compliance with Local/global change control procedures. 
• Review CRs and ensure the accuracy and completeness of all change requests. 
• Review the impacted validation deliverables.  
• Access Roster, Privacy and Periodic Review:  
• Contribute to internal and external audits, assessments or inspections. 
• Ensures IT system change requests (CR) are executed in compliance with Local/global change control procedures. 
• Review CRs and ensure the accuracy and completeness of all change requests. 
• Review the impacted validation deliverables.  
• Access Roster, Privacy and Periodic Review:  

Change Management:

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

How You Will Succeed:

• Achieving measurable improvements in validation efficiency (e.g., reduced cycle time, higher CSA adoption, increased compliance). 
• Contributing to continuous improvement for documentation and validation processes for functional areas. 
• Promoting simplification and harmonization across systems and geographies. 
• Mentoring and coaching junior validation staff, foster a quality culture across teams. 
• Driving CSA adoption to simplify and modernize CSV, focusing on risk-based assurance rather than excessive documentation. 

What You Should Bring:

• 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.  
• Experience in leading CSV activities across the full system lifecycle (implementation, upgrades, retirement). 
• Expertise in documents creation which includes, but not limited to validation plan, System Configuration, System Overview, Security Plan and validation report, etc. 
• Hands-on expertise in preparing, reviewing, and approving validation deliverables. 
• Strong knowledge of IT system operational compliance processes, including Periodic Reviews and Access Roster Reviews. 
• Proven ability to apply risk-based validation approaches in alignment with CSA principles to balance compliance with efficiency. 
• Hands-on experience with commonly used industry tools (e.g., Jira, ServiceNow, Veeva). 

Basic Qualifications And Experience Requirement:

• Bachelor’s degree in computer science, Information Technology, or a related field,  
• Overall 8-10+ years of experience in CSV in pharmaceuticals or life sciences industry.  
• Must have extensive knowledge of GxP, regulatory requirements, and IT system validation processes. 
• Demonstrated expertise in leading compliance initiatives and fostering cross-functional collaboration. 
• Strong experience in regulatory compliance, validation processes, risk assessment, IT systems change management, stakeholder collaboration, continuous improvement, project management, and analytical problem-solving. 
• Ability to collaborate with technical and non-technical team members. 

Additional Skills/Preferences:

• Excellent interpersonal, analytical, problem solving, and investigative skills. 
• Strong communication and collaboration skills. 
• Knowledge of Agile principles and frameworks (e.g., Scrum, SAFe), including related tools (such as Jira). 
• Demonstrated leadership skills and effectiveness in the areas of influence, team leadership, articulating and taking a position, negotiation, and conflict resolution. 

Additional Information:

Availability to work flexible work hours is/may be required. This 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.  Appropriate adjustments in benefits will be provided for employees working non-standard hours where applicable. 

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 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.

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