Analysis Skills, Change Requests/Orders, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Data Analysis, Data Quality, Regulations, Requirements Validation/Verification, ServiceNow, Site Evaluation, Software Development Lifecycle (SDLC), Standard Operating Procedures (SOP), Technical Analysis, Test Scripts, Validation Documentation, Validation Plan, Validation Testing
Senior CSV Engineer/Analyst
General lab instrument
validation requirements. worked in a lab or have done lab validation
before for at least a year or 2
CSV expert for that one.
Needs
to be a strong personality.
Needs to be onsite 4 days a week.
Needs
to be able to create all different validation documents as well as know data
integrity
10 plus years experience
Requirements
Responsible for supporting the
validation activities for local and global systems.
- Experience in developing and
maintaining validation documentation including validation plans, test
protocols, test scripts, and summary reports to align with company SOP and
regulatory standards.
- Coordinate with technical
evaluation with site Tech@Lilly subject matter experts (SMEs) of new and
existing systems from a DI and CSV perspective.
- Responsible for coordinating with
cross-functional teams to ensure the alignment of the validation activities.
- Perform data integrity gap
assessment and develop remediation plan for computerized systems.
- Responsible for creating
CAPA’s/Deviations and Change Requests in ServiceNow and Trackwise
- Experience using HPALM for
authoring and executing the Test scripts.
- Experience in
performing/supporting computer validations associated with SDLC deliverables