Consultant - Validation

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: Consultant - Validation

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

• 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.

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

Operational Compliance:

• Coordinate IT system operational compliance activities and ensure compliance with regulatory requirements and Lilly processes.

• 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.

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

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

Change Management:

• 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.

CAPA Management:

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

• Ensures IT CAPAs are implemented and closed on time.

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

Access Roster, Privacy and Periodic Review:

• 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 IT operational compliance (e.g., reduced review cycle time, timely CAPA completion).

• Contributing to continuous improvement for operational compliance processes.

• Promoting simplification and harmonization across systems and geographies.

• 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.

• 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.

• 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 5+ 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).

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.