CSV Engineer

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

Summary :

Roles & Responsibilities :

• Strong CSV and Quality expertise with ability to independently lead validation activities across the SDLC for GxP systems with minimal supervision. 7-10 years of relevant experience.
• Proven experience with Manufacturing, MES, and Data Platform Applications, including support for global and regional GxP computerized systems.
• Deep knowledge of GxP compliance, FDA/Global regulations, and Inspection Readiness.
• Expertise in validation documentation and deliverables, including review of compliance plans, requirements, design specs, test protocols, test scripts, defects, traceability, reports and system procedures.
• Demonstrated application of risk-based validation and risk management practices.
• Effective leadership and mentoring skills, guiding cross-functional and external teams (Senior and Junior consultants).
• Strong project coordination and stakeholder communication skills, including managing risks, issues, and status reporting.
• Experience in writing documentation (i.e. Compliance Plan, Test Plans, Test Reports, Compliance Summary Reports, and SOPs).
• Knowledge of Agile Tools (e.g., Jira, Xray, qTest, etc.).
• Ability to build collaborative partnerships, work as a team player and support execution of business objectives across teams, including timely escalations to TQ manager.
• Primary Language required: English. Strong verbal and written communication skills.
• Ability to work with dispersed/remote teams and support several projects simultaneously.
• Experience with Acquisitions/Separations/ Divestiture efforts is desirable.