Computer Systems Validation Analyst II

This is a fully remote position, open to applicants in United States.

📋 Description

• Assist with all facets of the Computer Systems Validation lifecycle.

• Generate documentation for the CSV lifecycle and carry out implementation tasks.

• Prioritize assignments and aid in managing escalation activities.

• Ensure adherence to regulatory standards, including 21 CFR Part 11, EU Annex 11, and data integrity protocols.

• Complete CSV activities and documentation, which encompass plans, risk assessments, user requirements, functional requirements, specifications, data integrity evaluations, testing, change controls, traceability matrices, qualification protocols, validation reviews, and compliance assessments.

• Provide support for the validation of laboratory, manufacturing, and enterprise multi-site applications that have a direct impact.

• Address inquiries from management, end-users, and clients while delivering regular status updates.

• Collaborate effectively to ensure the timely and budget-conscious delivery of validated computer systems to internal clients.

• Implement assigned action items related to change control.

• Oversee periodic reviews of computerized systems along with data integrity and quality.

• Execute additional duties as assigned.

⛳️ Requirements

• Bachelor’s degree in Information Technology, Life Science, or a related technical field.

• Over 5 years of pertinent industry experience.

• Proven project management skills with strong written and verbal communication abilities.

• Understanding of computerized system lifecycle functions, CSV, and IT controls within a regulated setting.

• Proficiency in 21 CFR Part 11, Annex 11, GAMP 5, and the data integrity principles of ALCOA+.

• Familiarity with Agile, Waterfall, and hybrid SDLC frameworks for regulated systems.

• Detail-oriented and organized, ensuring precision and compliance in documentation.

• Capability to work autonomously while overseeing multiple validation activities in a dynamic environment.

• Ability to foresee validation requirements and drive tasks to completion with minimal oversight.

• Must be able to maintain a standing or sitting position for extended periods.

• Must be able to navigate an office environment and occasionally lift, carry, push, pull, or move items weighing up to 10 pounds.

• Must possess visual acuity for data preparation and analysis, viewing computer screens, and extensive reading.

• Ability to perform repetitive motions with wrists, hands, and fingers.

• Ability to effectively communicate with others to exchange information.

🏝️ Benefits

• Competitive salary and comprehensive benefits package.

• Opportunities for professional development and career advancement.

• Supportive work environment that values innovation and collaboration.