Computer Systems Validation Analyst II

📋 Description

• Manage the computer systems validation lifecycle: Execute and document validation activities from
• Ensure regulatory compliance: Apply relevant regulatory standards, including 21 CFR Part 11, EU
• Develop validation documentation: Prepare and maintain validation plans, risk assessments, user and
• Support cross-functional system implementation: Collaborate with laboratory, manufacturing
• Coordinate project execution: Prioritize validation activities, track milestones, manage
• Manage change controls and periodic reviews: Complete assigned change-control actions and

🎯 Requirements

• Bachelor's degree in Information Technology, Life Sciences, Engineering, or another relevant
• At least five years of relevant industry experience in computer systems validation, quality
• Strong understanding of computer systems validation requirements, including 21 CFR Part 11, EU
• Demonstrated experience preparing and executing validation documentation, risk assessments
• Familiarity with computerized system lifecycle activities and IT controls, ideally supporting
• Ability to coordinate complex validation activities, manage competing priorities, meet deadlines

🎁 Benefits

• Annual base salary ranging from $120,000 to $135,000 USD, depending on work location, relevant
• Opportunity to work remotely in the United States, with a professional and well-equipped home
• Contribute to the quality, compliance, and reliability of systems supporting advanced biotechnology
• Opportunities to strengthen expertise in computer systems validation, regulated technologies, data
• Work with cross-functional teams across technical, laboratory, manufacturing, and enterprise
• Join an organization committed to equal employment opportunities, diversity, and an inclusive