Validation Consultant
7 days ago
Position: Computer System Validation Engineer (CSV Engineer) – Mid Level
Location: Wilmington, NC
Job Overview:
This mid-level CSV Engineer role requires experience in validating non-product software within the healthcare sector, ensuring adherence to FDA regulations. The role is crucial for validating computer systems used across development, manufacturing, and quality assurance.
Key Responsibilities:
- Validation of Non-Product Software: Validate software tools like MasterControl, Veeva Vault, TrackWise, SAP, and Oracle to comply with FDA standards.
- Risk Assessment: Conduct risk assessments to prioritize validation tasks.
- Documentation: Create and maintain key documents, such as User Requirements Specifications (URS), Validation Plans, Test Protocols (IQ, OQ, PQ), and Final Validation Reports.
- Validation Execution: Conduct IQ, OQ, and PQ tests to ensure the software functions correctly in operational settings.
- Collaboration: Work closely with IT, Quality Assurance, and Regulatory Affairs to align validation strategies.
- Compliance and Standards: Apply FDA guidelines (21 CFR Part 820), GAMP 5, and risk management practices to validation activities.
Qualifications:
- Education: Bachelor’s/Master’s degree in Computer Science or related field.
- Experience: Proven experience in software validation within regulated environments and semiconductor manufacturing is a plus.
- Skills: Strong analytical, communication, and documentation skills; familiarity with software testing methodologies.
- Tools and Knowledge: Proficient in various validation tools, able to work both independently and within global cross-functional teams.
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Position: CQV
Location: Vernon Hills, IL
Duration: 6+ months
Key Responsibilities:
- Equipment Support: Oversee equipment delivery, installation, and compliance with HSE policies.
- Project Management: Manage schedules, deliverables (HSE plan, RACI, risk analysis), progress tracking, and communications.
- Risk & Resource Management: Identify/assess risks, prioritize tasks, manage resources, and support CQV deliverables (Requirements, Protocols, Reports).
- Testing & Documentation: Assist with Pre-SAT, SAT, PQ execution and documentation, and prepare training materials.
Required Skills:
- 5+ years in equipment installation and CQV.
- Knowledge in automation, engineering disciplines, safety, and scheduling.
- Strong judgment, independent decision-making, and proactive issue resolution.
- Effective verbal and written communication.
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