What are the responsibilities and job description for the CSV Validation Consultant position at Reqroute, Inc?
Lab Systems Validation Consultant (CSV)
Location: West Point, PA (Onsite)
IMPORTANT
This position is strictly W2 only. C2C candidates, third-party vendors, staffing firms, employer representatives, and subcontractors will not be considered.
Position Overview
Client is seeking an experienced Lab Systems Validation Consultant with a strong background in Computerized System Validation (CSV) within regulated pharmaceutical environments. The ideal candidate will have hands-on experience validating QC and R&D laboratory systems, ensuring compliance with global regulatory standards, and supporting validation activities throughout the system lifecycle.
Required Experience
- Proven experience in Computerized System Validation (CSV) within pharmaceutical or life sciences organizations.
- Strong understanding of:
- FDA 21 CFR Part 11
- EU Annex 11
- GAMP 5
- Computer Software Assurance (CSA)
- Experience validating laboratory applications used in QC and/or R&D environments.
- Working knowledge of GxP regulations, including GMP, GLP, and GCP.
- Strong technical writing, documentation, and communication skills.
- Experience working within SDLC and V-Model validation frameworks.
Key Responsibilities
- Develop, review, and execute CSV deliverables for laboratory systems, computerized applications, equipment, and infrastructure.
- Author and maintain validation documentation including:
- URS (User Requirements Specification)
- MVP (Master Validation Plan)
- VP (Validation Plan)
- RTM (Requirements Traceability Matrix)
- TP (Test Protocols)
- IQ/OQ/PQ documentation
- VSR (Validation Summary Report)
- Ensure validation activities meet regulatory, quality, and compliance requirements.
- Support migration assessments, validation impact analyses, and due diligence activities across GxP and non-GxP environments.
- Provide guidance on quality management systems and regulatory compliance practices.
- Participate in regulatory inspections, audits, remediation efforts, and compliance initiatives.
- Collaborate with business, quality, and technical teams throughout project execution.
- Ensure all validation artifacts are inspection-ready and aligned with current industry standards.
Testing & Qualification Requirements
- Hands-on testing experience with at least one laboratory system supporting QC or R&D functions.
- Experience preparing and executing:
- Test Protocols (TP)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- Test Summary Reports (TSR)
- Traceability Matrix documentation
- Experience using testing and defect-tracking tools such as:
- Jira
- HP ALM
- Other test automation or validation platforms
Preferred Qualifications
- Experience implementing CSA-based validation approaches and risk-based testing methodologies.
- Familiarity with ServiceNow and Agile delivery environments.
- Exposure to AI-enabled validation or testing processes is a plus.
- Experience supporting regulatory audit responses and remediation programs.
Top Skills Required
✔ Computerized System Validation (CSV) in Pharmaceutical/Life Sciences Environments
✔ FDA 21 CFR Part 11, EU Annex 11, GAMP 5 & CSA Compliance
✔ Lab System Validation, Testing, and Qualification (IQ/OQ/PQ) for QC & R&D Systems