Description

Manage computer system validation processes and ensure regulatory compliance for computerized systems.

This role is on-site.

Responsibilities

• Facilitate computer system validation risk assessments to identify governing regulations and required deliverables.
• Review validation deliverables for projects managed by third-party suppliers.
• Plan, implement, and document user acceptance testing.
• Develop all documentation required for 21 CFR Part 11 projects, including Validation Plans and Summaries.
• Approve change requests related to validated computer systems and assess compliance practices independently.

Required Skills

• 4+ years of experience in computer system validation.
• Deep understanding of 21 CFR Part 11 requirements.
• Experience developing documentation to existing standards.
• Proficiency with Client ALM, JIRA, ServiceNow, and SAP Solution Manager.
• Advanced knowledge of MS Office suite and Visio.
• Ability to provide guidance on quality issues affecting data or system integrity.
• Bachelor's degree.

Key Skills

Education

Bachelor's degree