CSV Expert with knowledge of Kneat

Whitehall Resources Ltd; Germany; Remote; EUR 70,000 - 90,000; Full time

Job summary

A leading company is seeking an experienced Computer System Validation (CSV) Expert with hands-on Kneat knowledge for a freelance, fully remote role starting in Q4 2024. The position focuses on validation management and technical documentation within a regulated environment. The ideal candidate will lead CSV activities, implement validation strategies, and collaborate with stakeholders throughout the validation lifecycle. Strong technical writing skills and experience in a GxP-regulated environment are essential.

Qualifications

• Proven experience in CSV within a GxP-regulated environment.
• Strong validation management background across multiple systems.

Responsibilities

• Lead and manage CSV activities across systems and projects.
• Implement validation strategies aligned with GxP and regulatory standards.
• Prepare and maintain clear, audit-ready technical documentation.

Skills

CSV

Validation Management

Technical Writing

Kneat

Regulatory Knowledge

Tools

Kneat

Job description

Social Network Login/Join Platform

This role is for a CSV Expert with Kneat knowledge.

We are supporting a client in finding an experienced Computer System Validation (CSV) Expert with hands-on expertise in Kneat. This is a freelance, fully remote role starting in Q4 2024, focusing on validation management and technical documentation within a regulated environment.

Key Responsibilities:

1. Lead and manage CSV activities across systems and projects.
2. Implement validation strategies aligned with GxP and regulatory standards.
3. Utilize Kneat for documentation, workflows, and reporting.
4. Oversee validation plans, risk assessments, protocols, and reports.
5. Prepare and maintain clear, audit-ready technical documentation.
6. Collaborate with QA, IT, and business stakeholders throughout the validation lifecycle.

Required Skills & Experience:

• Proven experience in CSV within a GxP-regulated environment.
• Strong validation management background across multiple systems.
• Hands-on experience with Kneat software.
• Excellent technical writing skills in English.
• Knowledge of relevant regulations (e.g., FDA, EU Annex 11, GAMP 5).
• Self-motivated, detail-oriented, capable of working independently remotely.

Additional Information:

• Location: Remote
• Start Date: Q4 2024
• Language: English
• Contract Type: Freelance
• Duration: Initial with potential extension

Whitehall Resources specializes in ERP recruitment, including SAP, Oracle, and IT roles in the UK and internationally.

Applicants must be eligible to work in the specified country/location unless otherwise noted.

Whitehall Resources is an equal opportunity employer valuing diversity and inclusion. All qualified applicants will receive consideration without regard to race, religion, gender identity, sexual orientation, national origin, pregnancy, disability, age, veteran status, or other characteristics.