Senior CSV Validation Engineer - GxP & FDA Compliance

Creative Solutions Services, LLC; Raritan (NJ); On-site; USD 120,000 - 180,000; Full time

Job summary

Creative Solutions Services, LLC seeks an experienced GxP Validation Lead to independently drive validation activities for cGxP systems across the SDLC. You will guide cross-functional and external teams, ensuring proper documentation, risk-based validation, and regulatory readiness.

The role requires strong leadership, excellent communication, and hands-on expertise with validation plans, test scripts, and compliance reports.

Qualifications

• 7-10 years of experience in GxP validation and QA across SDLC.
• Experience with Manufacturing, MES, and data platform apps for global/regional systems.
• Deep knowledge of FDA/global regulations and inspection readiness.
• Expertise in validation deliverables: plans, requirements, specs, test scripts, reports.
• Risk-based validation and risk management practices applied to projects.
• Proven leadership and mentoring of cross-functional and external teams.
• Strong project coordination and stakeholder communication, with risk handling.
• Experience writing Compliance Plans, Test Plans, Test Reports, and SOPs.
• Proficient with Jira, Xray, and qTest; capable of remote collaboration.

Responsibilities

• Lead validation activities across the SDLC for GxP systems with minimal supervision.
• Coordinate cross-functional and external teams; manage risks, issues, and status.
• Develop and review validation documentation and deliverables.
• Ensure compliance with regulatory requirements and inspection readiness.
• Mentor junior consultants and provide effective leadership across projects.
• Communicate with stakeholders and help execute business objectives.

Skills

CSV / Computer System Validation

Quality Assurance

GxP compliance

Validation leadership

SDLC validation

Manufacturing systems

MES

Data Platform applications

Regulatory knowledge

Inspection readiness

Risk-based validation

Risk management

Leadership & mentoring

Project coordination

Stakeholder communication

Documentation writing

Agile tools usage

Remote collaboration

Mergers/Acquisitions experience

English communication

Tools

Jira

Xray

qTest

Job description

Creative Solutions Services, LLC seeks an experienced GxP Validation Lead to independently drive validation activities for cGxP systems across the SDLC. You will guide cross-functional and external teams, ensuring proper documentation, risk-based validation, and regulatory readiness.

The role requires strong leadership, excellent communication, and hands-on expertise with validation plans, test scripts, and compliance reports.