Overview

To execute and develop Computer System Validation (CSV) projects, both from a documentation and execution perspective, ensuring compliance with internal procedures, applicable regulatory requirements, and client expectations.

Key Responsibilities

- Execute technical and documentation activities within CSV projects under the guidance of the Project Leader.
- Collaborate closely with the assigned consulting team to ensure project consistency and quality.
- Ensure compliance with agreed timelines, deliverables, and quality standards.
- Regularly report project progress, incidents, and action plans to the Project Manager.
- Represent us in front of clients, safeguarding the company’s interests and corporate image.
- Accurately register and keep up to date working hours, expenses, and travel records.

Main Duties

- Request, review, and analyze technical information required to adapt validation documentation to the client’s methodology.
- Draft, review, and manage CSV consultancy documentation in accordance with our standards and current regulatory requirements.
- Perform validation activities, testing, training sessions, or technical support at the client’s facilities or at our HQ.
- Identify, document, and communicate any deviations or anomalies detected during project execution.
- Participate in data integrity assessments, infrastructure qualification, and software validation activities (ERP, QMS, LIMS, SCADA, HMI, etc.).





Requirements Academic Background

- Bachelor’s Degree or Diploma in Pharmacy, Engineering, Life Sciences, or related fields.
- Higher Vocational Training (HNC/HND) will be considered if supported by relevant professional experience.
- Training in project management.
- Specific courses in Computer System Validation, GAMP 5, Data Integrity, or related topics.

Technical Knowledge (Required)

- Solid knowledge of GxP regulations and regulatory requirements applicable to computerized systems.
- Experience in validation of laboratory systems, SCADA, ERP, QMS, LIMS, and similar platforms.
- Good understanding of pharmaceutical industry processes and operations.

Languages

- English: Advanced level (ability to manage information, write, defend and have fluent conversations in the language)

Professional Experience

- 2 to 4 years of experience in a similar role (CSV Consultant/CSV Technician).
- Previous experience participating in end-to-end CSV projects (documentation and execution).
- Experience working with clients and providing technical and documentation support.
- Exposure to international validation projects is a plus.

Additional Requirements

- Availability to travel (national and international). As for right now, the main projects are located across Cataluña. It will be desirable that the candidate has a driver’s license.

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📌 CSV Consultant - AJ Group (Barcelona)
🏢 Talent
📍 Barcelona