Computer Systems Validation (CSV) Specialist - Government Systems Technologies, Inc.

Direct hire or possibly CTH

Hybrid 2-3 days onsite in NewHaven, CT

2-3 interviews likely.

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.

• Excellent communication skills.

• Positive and engaging personality.