Manager - Validation Lead – Technical Support & Operations – Global Services
Eli Lilly and Company
August 18, 2026
Remote friendly (Indianapolis, IN)
United States
Operations
Job Title: Manager - Validation Lead – Technical Support & Operations – Global Services
Responsibilities
- Drive Computer System Validation (CSV) / Computer Software Assurance (CSA) activities to ensure compliance, quality, and efficiency.
- Innovate CSV processes by leveraging AI, digital tools, and automation to streamline documentation, authoring, and review.
- Lead and coordinate IT system validation across the computer system lifecycle (planning to reporting) to meet regulatory, Lilly process, and validation standards.
- Apply right-sizing approach and determine deliverables scope/content.
- Review/update AI/auto-generated validation documents for accuracy, compliance, and alignment with the quality management system.
- Review project validation deliverables authored by project team members.
- Escalate operational issues, critical compliance findings, and risks to Information System Quality (ISQ) and stakeholders.
- Educate project teams on IT processes and methodologies; collaborate cross-functionally to identify/mitigate compliance risks.
- Advise on implementation of compliance/security control requirements during system development.
- Support internal/external audits, assessments, and inspections.
- Ensure IT change requests (CRs) follow local/global change control; review CR accuracy/completeness and impacted validation deliverables.
- Facilitate access roster and periodic review; support CAPA closure.
How You Will Succeed
- Improve validation efficiency and compliance (e.g., reduced cycle time, higher CSA adoption).
- Drive simplification/harmonization and mentor junior validation staff.
Qualifications
- In-depth knowledge of CSV, data integrity, and computerized systems (GxP, GAMP 5, FDA 21 CFR Part 820/210/211/Part 11, EU Annex 11, ALCOA++).
- 8–10+ years CSV experience in pharmaceuticals/life sciences; lead full lifecycle CSV (implementation/upgrades/retirement).
- Expertise creating/reviewing/approving validation deliverables (e.g., validation plan, system configuration/overview, security plan, validation report).
- Strong knowledge of IT operational compliance (Periodic Reviews, Access Roster Reviews).
- Risk-based validation approach aligned to CSA principles.
- Hands-on experience with tools such as Jira, ServiceNow, Veeva.
Basic Requirements
- Bachelor’s degree in computer science, IT, or related field.
Preferred/Additional Skills
- Excellent interpersonal/analytical/problem-solving skills; strong communication and collaboration.
- Knowledge of Agile (Scrum, SAFe) and related tools (e.g., Jira).
- Demonstrated leadership and conflict resolution skills.
Additional Information / Application
- Flexible/non-standard work hours may be required (two shifts; some weekends/holidays).
Responsibilities
- Drive Computer System Validation (CSV) / Computer Software Assurance (CSA) activities to ensure compliance, quality, and efficiency.
- Innovate CSV processes by leveraging AI, digital tools, and automation to streamline documentation, authoring, and review.
- Lead and coordinate IT system validation across the computer system lifecycle (planning to reporting) to meet regulatory, Lilly process, and validation standards.
- Apply right-sizing approach and determine deliverables scope/content.
- Review/update AI/auto-generated validation documents for accuracy, compliance, and alignment with the quality management system.
- Review project validation deliverables authored by project team members.
- Escalate operational issues, critical compliance findings, and risks to Information System Quality (ISQ) and stakeholders.
- Educate project teams on IT processes and methodologies; collaborate cross-functionally to identify/mitigate compliance risks.
- Advise on implementation of compliance/security control requirements during system development.
- Support internal/external audits, assessments, and inspections.
- Ensure IT change requests (CRs) follow local/global change control; review CR accuracy/completeness and impacted validation deliverables.
- Facilitate access roster and periodic review; support CAPA closure.
How You Will Succeed
- Improve validation efficiency and compliance (e.g., reduced cycle time, higher CSA adoption).
- Drive simplification/harmonization and mentor junior validation staff.
Qualifications
- In-depth knowledge of CSV, data integrity, and computerized systems (GxP, GAMP 5, FDA 21 CFR Part 820/210/211/Part 11, EU Annex 11, ALCOA++).
- 8–10+ years CSV experience in pharmaceuticals/life sciences; lead full lifecycle CSV (implementation/upgrades/retirement).
- Expertise creating/reviewing/approving validation deliverables (e.g., validation plan, system configuration/overview, security plan, validation report).
- Strong knowledge of IT operational compliance (Periodic Reviews, Access Roster Reviews).
- Risk-based validation approach aligned to CSA principles.
- Hands-on experience with tools such as Jira, ServiceNow, Veeva.
Basic Requirements
- Bachelor’s degree in computer science, IT, or related field.
Preferred/Additional Skills
- Excellent interpersonal/analytical/problem-solving skills; strong communication and collaboration.
- Knowledge of Agile (Scrum, SAFe) and related tools (e.g., Jira).
- Demonstrated leadership and conflict resolution skills.
Additional Information / Application
- Flexible/non-standard work hours may be required (two shifts; some weekends/holidays).