Validation Analyst

Piper Companies is looking for a Validation Analyst to join a a premier Biotechnology organization in Lansing, Michigan. This is a contract opportunity, funded through the end of the year and requiring the candidate to report onsite.

Responsibilities for the Validation Analyst:

• Conduct system testing to verify that the upgraded Empower system and associated equipment function as intended once the system goes live
• Act as the primary point of contact for the Empower vendor, coordinating and escorting them during onsite activities related to system migration and upgrade
• Lead UAT efforts to ensure the system meets operational requirements and is ready for production use
• Collaborate with the vendor to troubleshoot any issues that arise during IQ/OQ/PQ phases, ensuring smooth implementation.

Qualifications for the Validation Analyst:

• Bachelors degree is related field is preferred but not required
• Demonstrated experience in validating software systems in regulated environments, including documentation and compliance with SOPs
• Experience with analytical equipment validation, even if not directly with Empower, is highly valuable
• Proven ability to lead or support UAT efforts, ensuring systems meet functional and regulatory requirements

Compensation/Benefits for the Validation Analyst:

• $75,000 - $100,000 per year (based of experience)
• Comprehensive benefit package; Medical, Dental, Vision, 401k, and Paid Time Off

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Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), User Requirements Specification (URS), Functional Requirements Specification (FRS), Design Specification (DS), Traceability Matrix, Validation Plan, Validation Report, Risk Assessment, Change Control, Configuration Management, Data Integrity, Audit Trail, Electronic Records, Electronic Signatures, 21 CFR Part 11, GxP Compliance, Good Automated Manufacturing Practice (GAMP), GAMP 5, Standard Operating Procedures (SOPs), Test Scripts, Test Cases, Test Protocols, Deviation Management, Corrective and Preventive Actions (CAPA), System Lifecycle, System Release Management, Regression Testing, Static Testing, Dynamic Testing, System Acceptance Testing, User Acceptance Testing (UAT), Qualification Protocols, Validation Master Plan (VMP), Backup and Recovery, Disaster Recovery, Access Control, Role-Based Access, Security Testing, Interface Validation, Data Migration Validation, System Integration Testing (SIT), Configuration Testing, Software Development Life Cycle (SDLC), Vendor Assessment, Supplier Qualification, Training Records, Documentation Control, Version Control, System Audit, Periodic Review, Revalidation, Legacy System Validation, Cloud Validation, SaaS Validation, Data Archiving, Data Retention, Metadata Validation, Environmental Monitoring, Sample Tracking, Chain of Custody, Barcode Integration, Instrument Integration, Calibration Records, Lab Workflow Validation, Batch Record Management, Sample Lifecycle, Quality Assurance (QA), Quality Control (QC), Compliance Audit, Regulatory Inspection Readiness, Validation Summary Report, Exception Reporting, System Downtime Analysis, Business Continuity Planning, IT Infrastructure Qualification, Network Qualification, Firewall Validation, Antivirus Validation, Patch Management, Software Release Notes, Validation Metrics, Validation Schedule, Validation Team Roles, Validation Deliverables, Validation Risk Matrix, Validation Traceability, Validation Evidence, Validation Review Board, Validation Approval, Validation Closure