Computer Systems Validation Specialist

Position Overview

This is a hybrid full-time position in our New Haven, Connecticut facility. The Computer Systems Validation (CSV) Specialist is responsible for ensuring that computer systems used in regulated industries like the pharmaceutical sector comply with industry standards and regulatory requirements (e.g., FDA, GxP, 21 CFR Part 11). This role involves the planning, execution, and documentation of validation activities for software systems, including hardware, software, infrastructure, and associated processes. The CSV Specialist works closely with cross-functional teams, including IT, Imaging Services, Image Analysis and Quality Assurance, to validate systems that support imaging CRO services.

Key Responsibilities:

• Validation Planning: Develop validation plans, protocols (IQ/OQ/PQ), and validation summary reports for computer systems to ensure they meet regulatory compliance and quality standards.
• Risk Assessment & GxP Compliance: Perform risk assessments and gap analyses to identify critical aspects of systems that impact product quality or patient safety. Ensure compliance with GxP regulations.
• System Development Life Cycle (SDLC): Oversee and support the entire SDLC of computer systems, from requirements gathering to design, testing, and deployment, ensuring validation is integrated throughout.
• Test Protocols & Execution: Create and execute test protocols (e.g., IQ, OQ, PQ) for system verification, ensuring proper functionality and integrity. Document and resolve any discrepancies or deviations.
• Change Control Management: Manage system changes through a controlled change management process, ensuring that system modifications maintain compliance with validation and regulatory requirements.
• Documentation & Reporting: Ensure comprehensive documentation for validation activities, including user requirements, functional specifications, test cases, test results, and validation reports.
• Audit & Inspection Support: Serve as a subject matter expert (SME) during regulatory audits and inspections, providing validation documentation and explaining validation strategies and processes to auditors.
• Training & Compliance: Provide training to team members and other stakeholders on validation requirements and best practices. Stay updated on regulatory changes and emerging industry trends.

Qualifications and Requirements: 

• Bachelor’s degree in computer science, Information Technology, Engineering, or a related field.

Preferred but not required:

• Advanced degrees or certifications in quality management or regulatory affairs are a plus.

Unique Department Requirements:

• 3-5 years of experience in computer systems validation within a regulated industry (pharma, biotech, medical devices, etc.).
• Knowledge of FDA 21 CFR Part 11 and other regulatory guidelines.

PLEASE NOTE:

Please note that since this is position is at least partially onsite, in the case of epidemic or other health crisis, employee must be willing to take reasonable steps to ensure that bacterial and viral infections are not spread to others including but not limited to temperature checks, vaccinations, exclusion from the office building, and other precautions as required by the building’s landlord.

What We Offer:

·        Competitive Salary

·        Comprehensive Health Insurance Plan

·        Long-Term Disability

·        Life Insurance

·        Retirement Plan

XingImaging, a Mitro Company provides equal employment opportunities to all employees and applicants for employment without regard to race, color, creed, ancestry, national origin, citizenship, sex or gender (including pregnancy, childbirth, and pregnancy-related conditions), gender identity or expression (including transgender status), sexual orientation, marital status, religion, age, disability, genetic information, service in the military, or any other characteristic protected by applicable federal, state, or local laws and ordinances. Equal employment opportunity applies to all terms and conditions of employment, including hiring, placement, promotion, termination, layoff, recall, transfer, leave of absence, compensation, and training.