CSV Engineer/Analyst

Pharmatek Consulting • Concord, NC

3d • Onsite

About The Position

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 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

Requirements

• 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

Responsibilities

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed